Quality Assurance Manager, New Product Introduction Anngrove, Cork Stryker is seeking aQuality Assurance Manager - New Product Introduction (NPI)to lead and advocate for design-for-manufacture and assembly excellence.
This role provides technical leadership in quality assurance for new product launches, ensuring robust process risk management and compliance with regulatory standards.
The ideal candidate will drive cross-functional collaboration to deliver high-quality, scalable products at launch.
Work Flexibility: Hybrid : Candidates must reside within a commutable distance to Anngrove, Cork site and be able to work onsite several times per week.
What you will do: Lead quality strategy for new product and technology development ensuring scalable, high-yield manufacturing processes.
Drive robust process risk management, including pFMEA, CQAs, and process validation.
Optimize inspection strategies through automation, lean principles, and supplier certification.
Ensure implementation and oversight of production and process controls throughout manufacturing.
Collaborate cross-functionally with design, operations, and global QA teams to ensure successful product launches.
Monitor and improve product quality performance metrics, identifying opportunities for continuous improvement.
Mentor and develop QA team members, supporting talent growth and performance excellence.
Ensure compliance with FDA, ISO, and Stryker corporate quality standards during product introduction.
What you need: Basic Qualifications: Bachelor's Degree in Engineering, Science discipline or related field.
8+ years of experience in a regulated manufacturing environment (Medical Device, Pharmaceutical, Biomedical, or Automotive).
Minimum of 3+ years experience leading and developing teams.
Preferred Qualifications: In-depth knowledge of FDA regulations, ISO standards, and experience managing regulatory inspections/audits.
Proficiency in quality tools such as SPC, FMEA, Root Cause Analysis, Poka-Yoke, and Six Sigma methodologies.
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