Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring a Senior Quality Engineer for our Global Quality Operations where youll play a key role in driving quality excellence and delivering impactful results. Were looking for a passionate advocate of quality and lean methodologiessomeone who thrives in a fast-paced environment takes initiative and communicates effectively across all levels of the organization. If youre a self-directed Quality professional committed to ensuring superior product quality for patients and customers we want to hear from you.
What you will do:
Operate independently within the Quality Operations team ensuring compliance and excellence in quality-related activities across products and processes.
Collaborate with cross-functional teams to drive quality performance lead manufacturing process improvements and support new product introductions.
Manages and provides oversight approval and mentorship in nonconformances and corrective action preventative actions (NC/CAPA) processes root cause analysis and problem-solving initiatives.
Review and approve change management validation and qualification activities for processes and equipment.
Monitor and analyze quality KPIs identify trends and implement corrective actions to maintain process integrity.
Apply advanced risk management and Human Factors principles to proactively identify and mitigate quality risks.
Optimize inspection methods support First Article Inspections and apply statistical tools to enhance product quality.
Represent Quality in internal and external audits lead quality efforts in manufacturing transfers and manage product holds and potential escapes.
Support the execution and analysis of manufacturing complaints and product field actions.
What you need:
Required Qualifications:
Bachelors Degree in a Science or Engineering related discipline.
Minimum of 2 years of experience as an Engineer working within quality manufacturing or new product development.
Experience in adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory standards.
Preferred Qualifications:
Proficient in medical device manufacturing processes with a strong understanding of ISO 13485 and industry standards.
Certification in one or more of the following: Certified Quality Engineer (CQE) Lead Auditor and/or Lean Six Sigma.
Required Experience:
Senior IC
Employment Type
Full-Time
