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New Product Introduction Quality Lead
2 weeks ago
Cork, Ireland
Stryker seeks a Quality Assurance Manager 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.
Key Responsibilities:
- 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 corporate quality standards during product introduction.
Requirements:
- Bachelor's Degree in Engineering 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 regulations and experience managing regulatory inspections/audits.
- Proficiency in quality tools such as SPC, FMEA, Root Cause Analysis, Poka-Yoke, and Six Sigma methodologies.
Benefits:
Hybrid work flexibility, commutable distance from Cork site, onsite work several times per week.
Other Opportunities:
Expand your professional network, enjoy an engaging work environment, contribute to company success.
