Our client is a highly successful, contract manufacturer in the medical device space.
The Quality Director reports to the VP of Quality & Compliance ensuring that systems and processes operate at the highest level of compliance and efficiency and are compliant to current regulatory requirements. The Director has hands-on oversight responsibilities for the quality associates in development and production, certifying product & process quality on the company’s products while assuring that requirements under applicable GxP regulations are met.
As the Quality Director you will interact daily across the breadth of the organization safeguarding the application of QMS requirements are being met from concept to commercialization.
- Maintains/improves the QMS in compliance with ICH, CFR, ISO and other applicable regs, including the writing and/or revision of standards, guidance and procedures
- Monitors and reports on site compliance to Practices, SOP’s, Work or Manufacturing Instructions, and other Regulated Documents
- Owns Document and Change Control assuring QMS documentation is effectively maintained
- Supports all internal and external audits
- Leads Management review and coordinates reporting on Quality Metrics
- Responsible for Supplier Quality process and metrics ensuring expectations are met
- Owns NCR and CAPA, identifies streamlining opportunities to improve effectiveness
- Is a champion for continuous improvement initiatives, drives performance improvements
- Interviews, trains, performs appraisals and salary reviews of assigned staff concurrent with HR requirements
- Provide the direction and oversight necessary to ensure the completeness, timeliness, consistency, accuracy and security (including storage) of Quality records
- Manage internal cGMP compliance audits to ensure adherence to cGMP regulations and company SOPs through the identification of areas of compliance vulnerability and risk, and provide guidance on the development/implementation of plans for resolution of problematic issues
- Monitor all GMP/GDP-related activities of the company to ensure compliance
- Develop clear understanding of various processes involved in all aspects of the production cycle to ensure proper quality measures are employed.
- Maintain current knowledge of FDA and international medical device regulatory standards
- Bachelor’s degree in Engineering or a related field is required
- 15+ years of quality experience is required with 6+ years in a manufacturing environment
- 5 years of leadership experience in a quality role is required
- Experience reading and interpreting blueprints and gage design knowledge is desired
- Must have extensive knowledge of ISO, GAMP 5, 21 CFR Part 11, 820 and EU MDR
- Experience with automated inspection systems is required
- Proficient in common quality methodologies related to design control and manufacturing
- Experience with Lean and Six Sigma methodologies is required
- Implementation of effective corrective action is required
- Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively