Quality EngineerLocation: Kalamazoo, Michigan
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:- Investigating product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
- Analyzing and trending post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
- Updating risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
- Participating in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
- Initiating, tracking, and documenting commercial product holds, ensuring timely resolution and accurate records.
- Supporting business units and commercial teams by providing post-market quality expertise and technical guidance.
- Facilitating and coordinating subject matter experts to develop technical documentation for product field action assessments and presenting findings to governance boards and senior leadership.
- Guiding research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness.
Qualifications: - Bachelors Degree in Engineering or related field.
- 2+ years in quality investigations, documentation, and print review.
- Experience working with change control processes and CAPA workflows.
- Strong communication skills.
- NC/CAPA experience, preferably with TrackWise.
- Data trending experience within medical device or pharmaceutical settings.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company