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StrykerAbout the role
What you will do
Build relationships with various divisions and business units.
Drive continuous improvement opportunities in Quality Assurance, including cost reductions.
Lead initiatives and projects to enhance quality performance and ensure compliance with regulations and standards.
Work closely with operations and business functions to ensure quality performance of products and processes.
Provide oversight and approval of NC (non-conformances) & CAPA (corrective action/preventative action), and mentor in problem-solving and root cause analysis.
Coach and develop less experienced engineers.
Participate in internal and external audits, providing effective narrative and expertise.
Apply statistical methods to ensure the reliability of the manufacturing process.
What you will need:
Required:
Bachelor’s Degree in Engineering (Biomedical, Mechanical, or related field)
4 years of experience in a regulated industry
4 years of experience in Quality Assurance and continuous improvement
4 years of experience with process and equipment validation/qualification
Preferred:
Internal Quality Auditor Qualification (ISO 13485, CFR 820, or comparable standards)
Knowledge of PFMEA (process failure mode and effects analysis), validation programs, and SPC (statistical process control) processes
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