Job Summary:
EPM Scientific is collaborating with a premier medical device company to recruit a skilled Quality Engineer for a 12-month onsite contract role in Minneapolis, MI. This opportunity offers a competitive hourly rate and an immediate start, targeting professionals with mid-level experience in medical device quality engineering, specifically in product engineering, change control, CAPA, and supplier quality.
Key Responsibilities:
- Oversee product engineering quality processes, ensuring alignment with industry standards and regulatory requirements for medical devices.
- Utilize Windchill PLM (Product Lifecycle Management) to manage product data, change control, and document management across the product lifecycle.
- Drive effective CAPA (Corrective and Preventive Actions) processes to address quality issues, including root cause analysis, corrective action implementation, and verification of effectiveness.
- Collaborate closely with suppliers to ensure compliance with quality standards and regulatory requirements, conducting audits and addressing any quality issues.
- Manage and execute change control processes, ensuring thorough documentation and approval of all changes impacting product quality.
- Maintain compliance with ISO standards and FDA regulations, contributing to the continuous improvement of quality management systems.
Qualifications:
- Mid-level experience (3-5 years) in Quality Engineering within the medical device industry.
- Proven expertise in product engineering, CAPA, change control, and supplier quality processes.
- Strong familiarity with Windchill PLM system for product lifecycle management.
- Medical device manufacturing experience is highly preferred.
- Solid understanding of industry regulations, including ISO and FDA standards.
- Strong analytical, problem-solving, and communication skills to collaborate effectively with cross-functional teams.
Work Schedule:
- 40 hours per week with onsite presence in Minneapolis, MI, required 3 days per week.
Why Apply?
This position offers the chance to work with a leading medical device company in a well-established role focused on ensuring the highest quality standards for life-saving products. With attractive hourly compensation and the support of a renowned recruitment team, this is an exceptional opportunity to advance your career in quality engineering.
