Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring a Senior Quality Engineer in Portage MI to support Medical Acute Care! In this critical role youll focus on post-market quality support leading efforts to enhance product and process performance. Youll be at the forefront of investigating field issuesmanaging complaints non-conformances (NCs) and corrective and preventive actions (CAPAs). Your expertise in root cause analysis and risk identification will directly contribute to resolving customer concerns and ensuring the continued excellence of our life-saving products.
Work Flexibility: Hybrid. This role requires proximity to our Stryker facility in Portage MI with at least three core onsite days (Monday-Wednesday). Additional onsite days may occasionally be required based on project needs.
What you will do:
Investigate and address sensitive customer complaints promptly ensuring compliance with global regulations and thorough communication with customers field service and sales teams to gather necessary information documenting results in the Complaint Handling System.
Collect analyze and present post-market data (such as service reports complaints and costs associated with poor quality) to identify and drive quality improvement opportunities within the Medical Division.
Support Nonconformances (NC) and Corrective and Preventive Actions (CAPA) processes including those that lead to field action assessments by collaborating with cross-functional teams (R&D Operations Manufacturing etc.) to identify root causes and implement corrections and corrective action.
Facilitate product changes through sustainment including Engineering Change Orders (ECO) and Process Change Orders (PCO) and develop rationales for verification or validation testing to resolve post-market issues.
Maintain and update risk management documentation throughout the product lifecycle conducting risk assessments as needed to ensure the current risk evaluation is complete and accurate.
Provide post-market feedback on safety durability craftsmanship and reliability to inform design input specifications for quality reports design reviews and customer research.
Support ongoing quality assurance for products post-launch by monitoring market feedback and customer input to improve safety and effectiveness.
Monitor compliance with Medical Quality Procedures FDA and other global health regulations and assist with internal and external audits (FDA ISO MDSAP etc.).
What you need:
Required Qualifications:
Bachelors degree in an Engineering related disciple.
Minimum of 2 years of hands-on engineering experience with the ability to apply engineering principles to solve complex problems and drive continuous improvement initiatives.
Preferred Qualifications:
Experience working in a cGMP (Current Good Manufacturing Practices) and GDP (Good Documentation Practices) within FDA-regulated industries such as medical devices pharmaceuticals or biotechnology
Demonstrated experience in Quality Assurance/Quality Control (QA/QC) with a strong focus on managing non-conformances (NC) executing corrective and preventive actions (CAPA) and handling customer complaints in compliance with regulatory and quality standards.
Basic understanding of key industry regulations and standards including FDA Quality System Regulation (QSR) ISO 13485 for medical device quality management systems and ISO 14971 for risk management.
Required Experience:
Senior IC
Employment Type
Full-Time
