Quality Assurance Assistant Director, Combination Product & Medical Device Development
Primary responsibility is as the QA lead on R&D combination new product development teams. Mentor/lead product team members through the design control process. Provide product QA support for design control and risk management. Utilize quality engineering methods.
- Provide QA support for new drug-device Combination Product development from late stage feasibility through transfer into commercial and/or clinical manufacturing operations
- Perform and review/approve design control and risk management activities. Work closely with research and development organization to ensure potential product issues are identified and addressed in the design.
- Work effectively and influence multiple functions (R&D, Operations, Commercial, Regulatory, Supply Chain, Medical, etc.) to ensure design control expectations are met
- Perform 3rd party management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development, etc.
- Ensure compliance with corporate and regulatory body requirements for medical devices and combination products
- Support resolution of project team issues with minimal oversight
- Work on complex technical problems, utilize quality engineering methods and provide innovative solutions
- Interact with and have ability to influence decisions of R&D and Operations Directors and Vice Presidents. Requires high level of competence, confidence, and credibility.
- Provide consultation and training on combination products and medical devices to internal and cross-functional groups
- Lead quality system improvement initiatives
- Assure integration of device, drug and biologic regulations into the quality system
- Represent the company as the combination products Quality Assurance subject matter expert during internal and external regulatory inspections.
- Ensure design control documentation and requirements are met.
- Bachelor's degree is required; typically in sciences, engineering or other technical/scientific area
- Master's & above degree preferred. Engineering degree preferred
- 7-10 years of experience in Quality, Development or related field
- Device regulation (design control) experience required
- Combination product and experience with supplier management preferred
- Leadership of other technical professionals and experience in leading global cross-functional teams with results-orientation
- Skilled in the initiation, selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative
- Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products
- Knowledge of ISO standards, US Code of Federal regulations, and the EU regulations
- Conflict resolution skills including persuasive management techniques required
- Strong oral and written communication skills needed
- Excellent interpersonal skills required
- Makes critical, creative and strategic decisions as a result of rapid analysis of available information including risk-assessment for the patient and for the business
- Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the different functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements
Level of position is commensurate upon education and experience of the candidate.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled