Plan and direct activities concerned with the design, development, application, implementation and maintenance of quality standards to ensure that all new and existing products meet their requirements for safety and effectiveness.
Ensure that all new products and changes to existing products and processes are formally validated, documents and approved prior to their implementation into routine production.
Ensure the maintenance of quality standards during routine production.
- Design and development of test equipment, methods and procedures.
- Determine scope and specific requirements for Process Validations not associated with PDP.
- Support PDP projects as the QA team member.
- Create associated Design Controls documents for which QA is responsible (UFMEA, DFMEA, PFMEA, DVMP, DV protocols and summaries, PV protocols and summaries)
- Purchase of new test equipment required.
- Coordination of activities associated with validation pilots.
- Assist in the development of new or changed product performance specifications.
- Determination of regulatory requirements of new products.
- Validation of new test methods.
- Qualification of new material/component suppliers.
- Represents QA at Project Reviews.
- Provide statistical support for design verification and validation of new products.
- Responsible for release (including PN changes) of CO’d product.
Provide 'Customer Service” support.
- Solve Mfg. problems and recommend product/process changes as a corrective action.
- Review current test methods, equipment, and procedures to determine the need for change or additions.
- Approve CO’s, Emergency Instructions, Deviation Reports, etc. in the absence of the QA Manager.
- Determine the acceptability of non-conforming product.
- Train QA Process Auditors and conduct periodic training sessions.
- Write procedures for inspection of materials, components and products.
- Improve test methods to reduce inspection time.
- Assure everyday compliance to GMP.
- Perform a failure analysis on returned goods and provide corrective actions, where possible, to prevent a repeat failure.
- Answer technical questions regarding quality performance and sterilization directly to Territory Mgrs., physicians, nurses, technicians and OEM customers.
Firm grasp of medical device validation requirements and methods (IQ, OQ and PQ), and related QSR requirements.
- Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, ISO and military.
- Technical writing and oral communication skills.
- Firm grasp of probability and statistics.
- BS/BA in Engineering and/or Science Related discipline or equivalent experience.
- Seven years of related (medical device or pharmaceutical industry) work experience.