Quality Engineer
Location: Grand Rapids, Michigan
About Our Client:
Our client is a well-established medical device manufacturer located in the Greater Grand Rapids area, specializing in the development and production of high-quality surgical products used by healthcare professionals worldwide. The organization is known for its strong commitment to patient safety, innovation, and operational excellence, and offers a collaborative, quality-driven environment focused on continuous improvement.
Key Responsibilities:
- Ensuring products and processes meet quality, regulatory, and customer requirements.
- Investigating nonconforming product, leading root cause analysis, and implementing effective corrective and preventive actions (CAPA).
- Supporting manufacturing and engineering teams to resolve quality and technical issues while reducing scrap, downtime, and defects.
- Participating in new product introductions and process changes, including PFMEA/DFMEA, PPAP, validation, and risk build activities.
- Developing and maintaining inspection methods, gauging strategies, test procedures, and quality documentation
- Performing process capability studies, gauge R&R, and data analysis to identify trends and drive continuous improvement.
- Supporting customer complaint investigations, supplier quality issues, and product disposition decisions.
- Maintaining and improving the Quality Management System in compliance with FDA, ISO 13485, and other applicable regulations.
- Creating, updating, and training on quality procedures, work instructions, and quality alerts.
- Participating in internal, customer, and regulatory audits and supporting audit readiness.
- Using quality metrics and reporting to communicate findings and recommend improvements to management.
Qualifications:
- Bachelor’s degree in Engineering or a technical discipline preferred.
- 3+ years of experience leading or supporting quality improvement projects preferred.
- 2+ years of experience in a regulated industry (FDA and ISO environments preferred).
- ASQ certification a plus.
- Strong communication and interpersonal skills with the ability to work across all levels of the organization.
- Ability to adapt and remain effective in a fast-paced manufacturing environment.
- Strong teamwork mindset and positive attitude.
- Ability to read and interpret technical prints and drawings.
- Proven problem-solving skills, including root cause analysis and corrective action implementation.
- Project management skills with the ability to manage multiple priorities.
- Experience conducting PFMEA.
- Experience with 3D modeling; SolidWorks preferred.
- Proficiency with Microsoft Office and related computer tools.
- 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
