Careers

Position Summary:

Provide custodial support for all facility locations and production environments. Contribute to efficiency and professional atmosphere of facility through thorough cleanliness of facility and timeliness of deliveries.

Essential Duties and Responsibilities:

• Collect/deliver mail per designated mail runs to each location on a daily basis.
• Strip and wax floors and wash windows and other periodic tasks.
• Dispose of finished pharmaceuticals per prescribed procedures.
• Manage, maintain and order consumable products for on hand stock and storage closets.
• Clean facilities including; offices, labs, lunchrooms, warehouse, bathrooms, halls and production on a routine basis.
• Coordinate and organize other custodial staff as appointed by Maintenance Supervisor.

Working Relationships (internal/external):

• Internal: All employees in the WI facilities. Assist other associates with tasks as needed.
• External: Any guests or visitors of the WI facilities.

Decision-Making Authority:

This position has the authority to:

• Perform, with minimal supervision, those tasks required to successfully complete assigned tasks.
• Bring to the attention of their immediate supervisor or the Director of Quality Assurance any incident that could negatively impact corporate goals and or regulatory compliance requirements.

Position Requirements and Competency Measurements

Education and/or Experience:

High School Degree or equivalent. Prefer some work experience.

Knowledge, Skills and Abilities:

Ability to manage time and responsibilities efficiently, reliability; strong desire to have things clean and tidy.

Certifications, Licenses, Registrations:

Requires a regular valid operator driver license to perform job related tasks.

Physical Demands:

Lift up to 75 lbs., physical exertion for cleaning tasks, utilizes floor scrubbing and other custodial / maintenance equipment. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

The work environment characteristics described are representative of those an employee encounters while performing the essential functions of this job.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Candidate will coordinate the control, testing, calibration and troubleshooting of manufacturing and laboratory equipment for conformance to established standards; this includes developing calibration methodology and procedures for newly installed instrumentation and equipment, and support equipment Installation and Operational qualification activities as required.

Essential Duties and Responsibilities:

• Coordinate the calibration of all manufacturing and product testing equipment.
• Develop calibration methodology and procedures for newly installed instrumentation and equipment.
• Generate calibration documents and analyze test results in accordance with internal SOP’s and cGMP requirements.
• Organizes and maintains inventory of all supplies/standards needed for calibration.
• Support Installation and Operational Qualification activities for new equipment or systems installed including those requiring computerized operation/interfacing. Coordinate other activities associated with installation and proper configuration of new equipment as directed.
• Support proper Configuration Management of new equipment and perform audits existing equipment configuration as directed.
• Review and approve calibrations and supporting documents performed by external calibration services.
• Collect and compile data necessary for the preparation of reports in response to deviations, root cause analysis or Corrective/Preventive Actions.
• Learn and support other Quality System functions as assigned by Quality Assurance Management personnel that may be related to documentation review, Nonconformance review, Corrective and Preventive Actions, First Article Inspections, product complaint investigations, audits, environmental testing and other tasks as directed.
• Learn, understand, and promote the use of the Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.

Working Relationships (internal/external):

• Internal: All departments
• External: Component/service suppliers, customers

Decision-Making Authority:

This position has the authority to:

• Specify manufacturing and other equipment needed.
• Perform, with minimal supervision, those tasks required to successfully complete assigned projects.
• Bring to the attention of their immediate supervisor or the Director of Quality Assurance any incident that could negatively impact corporate goals and or regulatory compliance requirements.

Position Requirements and Competency Measurements

Education and/or Experience:

Minimum two-year associate degree in metrology or related field four year degree preferred. Experience working with hand tools, calibration equipment, and electrical test equipment. Minimum 2 years in the medical device field or other Quality Control/Quality Assurance trade desired.

Knowledge, Skills and Abilities:

Working knowledge of fundamental metrology/calibration concepts and practices. Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality System Regulations, GMP’s and/or other international medical device regulations. Possess excellent written and verbal communication skills. Computer skills including those associated with the operation of manufacturing/testing equipment, word processing, spread sheet programs, databases and statistical analysis. Ability to prepare testing protocols and reports, operating documents and procedures. Ability to work with little or no supervision, and make effective decisions.

Certifications, Licenses, Registrations:

ASQ Certified Calibration Technician, Quality Technician, Quality Engineer, or equivalent desirable.

Physical Demands:

Some clean room work required; no make up or excessive amounts of jewelry allowed. Lifting of light to moderately heavy (less than 25 pounds) objects. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

The work environment characteristics described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Support all activities associated with the sterilization of BioForm products. Coordinate and execute in house sterilization process validations and support all contracted sterilization activities associated with manufactured products. Advise Quality Assurance, Manufacturing and R&D departments on matters related to product sterilization. Evaluate the operation of Manufacturing and Quality Assurance activities in relation to sterilization compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality Assurance Management and other Quality Assurance personnel regarding operation of the department and Quality System.

Essential Duties and Responsibilities:

• Learn the Manufacturing and Quality Assurance activities associated with the in-house sterilization (steam) of BioForm Medical products.
• Coordinate and oversee contract sterilization activities associated with the manufacture of BioForm Medical products including those related to EtO, radiation, and/or steam as required.
• Plans, schedules and leads sterilization-related projects with the ability to leverage various engineering techniques, procedures and criteria with minimal guidance.
• Prepares and coordinates sterilization product and process validation master plans, protocols, and reports to insure product quality and Quality System requirements are met.
• Maintain processing specifications and required documents to include load configuration, sterilization specifications and manufacturing documents, as needed.
• Learn, coordinate, and analyze databases associated with oversight of product and process sterilization and its reporting process. Provide Corrective Actions where indicated.
• Provide on-going support for manufacturing related sterilization operations including: process improvements, troubleshooting of sterilization equipment, process, and material related issues, complaint trend review, and resolve non-conformances.
• Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required.
• Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
• Perform Internal and Supplier Audits where appropriate.
• Provide backup in reviewing and approving internal operating procedures and specifications.
• Provide support to other BioForm departments as required.
• Support all activities associated with the operation of the Quality Assurance department and advise departmental management on all such matters.

Working Relationships (internal/external):

• Internal: All departments
• External: Customers, patients, regulatory bodies, suppliers

Decision-Making Authority:

This position has the authority to:

• Direct and control the efforts of project teams as appropriate.
• Specify testing, inspection and other equipment needed.
• Perform, with minimal supervision, those tasks required to successfully complete assigned projects.
• Bring to the attention of their immediate supervisor or Management any incident that could negatively impact corporate goals and /or regulatory compliance requirements.

Position Requirements and Competency Measurements

Education and/or Experience:

Minimum of 3 years experience with sterilization process engineering in the medical device industry, pharmaceuticals or biologics. Associate Degree required; BS in a Microbiology, Biology or Physical Science preferred.

Knowledge, Skills and Abilities:

Strong technical and general problem-solving skills required. Ability to work with company staff and communicate effectively throughout the organization is essential. Preferred experience with the sterilization of medical devices including Steam, EtO, and Radiation processes, and testing methods associated with those processes. Preferred experience in performing internal and/or supplier audits. Preferred experience in training of personnel. Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.

Certifications, Licenses, Registrations:

Affiliation with relevant professional organizations preferred (e.g., AAMI). ASQ Certification as a Quality Engineer, Quality Auditor or equivalent desirable.

Physical Demands:

Some clean room work may be required. Lifting of light (less than 15 pounds) objects. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

The work environment characteristics described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

The Associate Tradeshow Manager will play a key role in the management of Aesthetic and Voice Tradeshows. This position will manage all tradeshow activities for Tier 2 (national aesthetic) conferences and ENT (voice) conferences including planning and execution of events. A strong focus on medical society relationships is key.

Essential Duties and Responsibilities:

• Research and identify key national meetings and conventions; make recommendations regarding participation
• Manage participation at Tier 2 and Voice tradeshows including planning, execution and post-show follow-up
• Negotiate sponsorships and leverage opportunities to maximize marketing opportunities for the product line; liaison with Grant Committee
• Responsible for staffing Tier 2 and Voice tradeshows and ensuring staffers obligations are fulfilled
• Collaborate with marketing team to develop and execute pre-show marketing efforts where applicable to include advertisements, e-blasts, door drop and bag inserts
• Update tradeshow calendar in a timely fashion
• Establish and build key industry relationships with medical societies to augment marketing programs and products
• Lend support to other tradeshow activities which may include Tier 1 and/or Tier 3 conferences
• Attend key conferences and meetings to ensure objectives are met
• Assist with writing and publishing of internal newsletter
• Responsible for managing Tier 2 and Voice shows within budgetary limits
• Other duties as assigned

Position Requirements and Competency Measurements

Education and/or Experience:

• Bachelor’s degree in marketing or related field required.
• Minimum 5 years experience in marketing with at least 2 years direct tradeshow experience.
• Prior medical device and/or pharmaceutical industry experience highly desirable.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Provides strategic direction of regulatory, policy and standards (PhRMA, AdvaMed) requirements in the development and implementation of marketing strategy and promotional programs. Works collaboratively with commercial organization to ensure promotional and advertising practices are consistent with regulatory requirements/guidelines and also supports business objectives. Proposes creative solutions to challenging promotional concepts that meet business objectives and also minimizes regulatory risk. Serves as the primary regulatory advertising and promotion reviewer for multiple product lines (pharmaceuticals and medical devices).

Requires a high degree of interaction with governmental agencies and BioForm employees at all levels within the organization. Consults with Vice President, Regulatory Affairs as necessary.

Essential Duties and Responsibilities:

• Reviews and approves proposed advertising and promotional materials for multiple product lines (pharmaceuticals and medical devices).
• Develops and implements effective strategies for FDA (DDMAC) submissions.
• Prepares submissions of promotional materials for FDA (DDMAC) review and comment.
• Manages correspondence with FDA (DDMAC) and interpretation of advisory comments.
• Maintains a productive relationship with the FDA (DDMAC) to ensure successful and timely review of advisory submissions and effective resolution of regulatory issues.
• Functions BioForm point of contact in written and verbal communications with FDA on issues related to advertising and promotional materials.
• Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical and medical device industries.
• Ensures changes in Prescribing Information are reflected in promotional and advertising materials.

Position Requirements and Competency Measurements

Education and Experience:

• BA, BS or advanced degree with an emphasis in science, health care or related fields.
• Minimum 5 years experience in the regulatory review and approval of professional and consumer prescription pharmaceutical advertising and promotion including experience with regulatory activities involved with a product launch. Medical device advertising and promotion experience desirable.
• Experience in leading activities for promotional DDMAC submissions (including pre-clearance and 2253, “time of first use” submissions).
• Extensive experience with marketing concepts/tools, and product development process including labeling development.
• Proven ability to analyze and interpret efficacy and safety data.
• Proficient with Microsoft Office applications.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Increase awareness of and education regarding BioForm products and technologies in the medical marketplace by developing and implementing effective curriculum materials, supporting continuing medical education programs through corporate grant structure, and managing and facilitating physician training events and programs. Accounts and customers include Plastic Surgeons, Facial Plastic Surgeons and Dermatologists both in private practice and in academic (teaching) centers and hospitals. Provide support for and assessment of ongoing clinical education activities and oversee implementation of safe and effective clinical practices for use of BioForm Medical products. Provide technical and procedural training for internal customers including sales, field clinical specialists, and marketing.

Key Criteria:

• Corporate experience, preferably in a marketing role or at minimum a role interacting with marketing, such as Medical Affairs.
• Knowledge of compliance and regulations of a company operating under PhrMA and/or AdvaMed and FDA guidelines.
• Technical knowledge, such as a background in chemistry, biology, or equivalent experience.
• Experience with content development for physician facing materials and messages.
• Team player who is able to drive projects to completion in conjunction with multiple stakeholders and ability to prioritize projects.

Essential Duties and Responsibilities:

• Develop educational programs for training of safe and effective clinical practices for healthcare practitioners, through direct communication channels and internally by messaging sales representatives. Specifically, generate opportunities to impart clinical knowledge and data on the use of BioForm Medical products and devices, including clinical education documents and support materials to effectively arm sales representatives and field clinical specialists and direct educational support for physicians and outside training providers.
• Develop content for training and dissemination of clinical applications, techniques and data for existing and upcoming products. Methods of dissemination to include workshops, hands-on sessions, trade shows, FCS field demos, etc.
• Provide technical and medical content for relevant marketing initiatives and materials. This includes performing Medical Affairs review of marketing materials for accuracy and completeness of information.
• Develop materials with internal stakeholders for dissemination of clinically-relevant information to physicians in response to unsolicited inquiries. Understand and anticipate potential topics of inquiry and prepare scripts and documents to address topics.
• Facilitate grant support of investigator initiated trials and CME activities, etc. Collaborate with internal departments to determine strategy for grant commitments and communicating those to the Grants Committee. Build relationships with external vendors to ensure project success.

Position Requirements and Competency Measurements

Education and/or Experience:

• BA/BS in a scientific discipline or relevant experience, Masters degree preferred.
• Require working knowledge of Aesthetics industry.
• A minimum of 3 years experience in developing clinical education tools and/or content, with Marketing or Medical Affairs focus.

Knowledge, Skills and Abilities:
Procedural, technical, scientific and anatomical competency for development of educational materials. Thorough understanding of the relationships among physicians and extenders, professional organizations and industry support for clinical education initiatives. Ability to work independently on clinical education projects, and meet deadlines. Strong problem-solving and prioritizing skills. Ability to influence and gain consensus without authority. Excellent business writing and communication skills, i.e. reports and letters and usage of Word, Excel, PowerPoint.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Responsible for general accounting and general ledger support.

Essential Duties and Responsibilities:

• Compiles and analyzes financial information in order to prepare and enter journal entries into the general ledger maintained in QAD.
• Processes daily and month-end sales reports for management review.
• Prepares end of month commission calculations utilizing Xactly.
• Assists with preparation of monthly Management Reporting Packages.
• Performs analysis of accounts receivable and the allowance for doubtful accounts.
• Performs reconciliations of various balance sheet and income statement accounts.
• Maintains fixed asset system in QAD.
• Assists with monthly budget vs. actual reporting.
• Performs internal controls and assists Supervisor to monitor compliance of Finance group and other departments with the Company’s internal control policies and objectives.
• Analyzes financial information detailing assets, liabilities, and capital, and reviews and verifies balance sheet, profit and loss statement, and other reports to summarize current and projected company financial position.
• Evaluates subsidiary journals and transactions for errors and omissions and enters corrected data.
• Ensures timely processing of financial statements.
• Assists with year-end audit.
• Performs debit and credit memo maintenance.

Position Requirements and Competency Measurements

Education and/or Experience:

• Bachelor’s degree in Accounting from a four-year college or university required.
• 0-2 years related accounting experience.
• Ability to read and comprehend complex accounting literature such as IFRS and FASB’s preferred.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Under the direction of the Accounting Operations Manager, the Payroll Specialist ensures the accurate and timely processing and payment of all payrolls for the company and related state and federal taxes.

Essential Duties and Responsibilities:

• Maintains and updates company payroll records.
• Prepares and processes bi-weekly payroll checks, monthly commissions and other adjustments necessary using PayChex.
• Directs compilation and preparation of other payroll data such as 401K, insurance, and garnishment payments.
• Reviews and approves payroll deductions.
• Interprets company policies and government regulations affecting payroll procedures.
• Ensures the scheduled deposit of state and federal withholding taxes and the timely preparation of state and federal payroll reports.
• Maintains quarterly earnings in preparation of W-2’s.
• Maintains time and attendance information.
• Addresses and resolves payroll problems with employees.
• Reviews departmental processes and methods and makes recommendations for efficiency improvements.
• Ensures compliance with procedures and quality and safety regulations.

Position Requirements and Competency Measurements

Knowledge, Skills and Abilities:
At least seven years of related experience in payroll utilizing a computerized process; or a combination of experience and education. Extensive Experience with Paychex and ADP preferred. Demonstrated knowledge of payroll issues including taxes, deductions, FICA, etc. CPP designation preferred.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Responsible for directing the planning, development and management of the company’s IT system infrastructure, software applications and communications technology. This position is highly visible and strategic in nature to ensure organization’s technology needs are appropriately identified and resourced in a manner consistent and compliant with corporate goals and objectives.

Essential Duties and Responsibilities:

• Leads process of developing and implementing IT network and infrastructure across multiple facilities and locations internationally supporting approximately 500 systems.
• Responsible for communications technology, including blackberry and other telephony services, company’s local area network and remote access capabilities for company’s field users.
• Oversees software applications, including Customer Relationship Management (CRM) system, QAD Enterprise Resource Planning (ERP) system, and other software packages across multiple sites.
• Engages in long-term planning and strategy to define future requirements for system improvements on the basis of technological developments and internal functional needs.
• Responsible for budget planning and management as well as staff hiring, training, career development, and supervision of Information Technology and Applications Systems department personnel.
• Communicates effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, and provides senior level resolution to internal client issues.
• Lends expertise to internal teams and task forces and participates in company planning functions. Reviews and reports on status of objectives to the information technology teams and senior management.
• Responsible to ensure the reliability, efficiency, compliance and confidentiality of information systems with applicable regulations.
• Develops system with provision for continuity of operations during any disaster recovery or other emergency situations.
• Responsible for development and enforcement of standard policies and procedures for a regulated environment.

Position Requirements and Competency Measurements

Education and/or Experience:

• Bachelor’s degree in computer science and 10 years or more related experience. MBA preferred.
• Minimum of 5 years experience managing an IT department, preferably in a multi-site environment.

Knowledge, Skills and Abilities:
Excellent analytic, communication, presentation and management skills. Proven proficiency in latest technology for IT and applications system and management; ability to manage projects and establish relationships in a common language with other personnel.

We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.

Position Summary:

Provide assistance to internal/external customers for all aspects of customer service. Process sales orders received via phone/fax/email in an accurate and timely manner. Process and problem solve issues related to order entry and delivery in a manner that reflects positively on the company and fosters good will with both external and internal customers; ensuring prompt resolution to problems.

Essential Duties and Responsibilities:

• Process and document U. S. and International Sales Orders.
• Process returns requests.
• Establish new customer profiles, both domestic and international.
• Assist customers with resolving issues related to product availability and delivery. Track through carrier.
• Process invoice payments.
• Assist with product complaints.
• Perform varied administrative tasks necessary to the department’s function.
• Assist with filing and maintaining filing drawers.
• Review current promotions with customers

Position Requirements and Competency Measurements

Education and/or Experience:

• High School diploma/GED Equivalent required; prefer additional formal training.
• Minimum of two years related customer service experience preferably in high-volume call center environment.

Knowledge, Skills and Abilities:
Ability to thrive in a fast-paced environment during periods of high call volume. Good communication, listening, and business writing skills required. Good problem-solving skills required. Strong computer skills with Microsoft Office. Highly detail-orientated, accurate, organized, and ability to multi-task. Excellent interpersonal skills, able to work as a member of a team. Bilingual in English/Spanish is a plus.

We offer competitive benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to HR@bioformmedical.com or fax to: (262) 835-3329.