Post Market QE
Location: Kalamazoo, Michigan
About Our Client:
Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!
Key Responsibilities:
- Manage and analyze customer complaints, field failures, and warranty claims.
- Drive root cause investigations and implement effective corrective actions.
- Develop product return and evaluation processes as part of complaint handling.
- Collaborate with cross-functional teams (engineering, service, regulatory, etc.) to ensure timely resolution and proper documentation.
- Generate regular trend reports and insights to identify systemic issues and recommend improvements.
- Support QMS integration activities following the acquisition of a software company.
- Maintain and improve QMS documentation, procedures, and work instructions.
- Align quality processes with industry standards (ISO 9001, ISO 13485, ISO 27001, TL 9000).
- Create and refine process maps with post-market and cross-functional stakeholders to guide SOP development.
- Support preparation for audits and regulatory inspections.
- Facilitate training sessions on updated quality procedures and system changes.
- Ensure compliance across all stages of the product lifecycle—design, production, service, and post-market.
- Assess potential quality risks and provide recommendations to mitigate issues.
- Lead or support CAPA, nonconformance, and risk management activities.
- Recommend and drive continuous improvements in quality practices and system effectiveness.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
- 3+ years of experience in Quality Assurance or Quality Engineering within a regulated industry (medical device, pharma, or related).
- Strong knowledge of ISO 13485 and 21 CFR Part 820.
- Experience with complaint handling, CAPA, and nonconformance management.
- Proven ability to analyze data and drive process improvements.
- Experience with software or digital health products (regulated or non-regulated).
- Familiarity with ISO 27001, TL 9000, or other software-related standards.
- Knowledge of post-market risk assessment, product lifecycle management, and integration projects.
- Experience supporting regulatory audits and internal inspections.
- Exposure to QMS integration or acquisition environments.
- 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
