Senior Quality Engineer - (CONTRACTOR)

Evergen • Eden Prairie, MN

16h • Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. The company offers a differentiated portfolio of allograft and xenograft biomaterials at scale and is headquartered in Alachua, FL, with manufacturing facilities in various locations including Eden Prairie, MN. This role is a full-time contractor position based 100% onsite at the Eden Prairie, MN site. The Senior Quality Engineer will act as a quality lead for major design and manufacturing projects, ensuring robust risk management and compliance. Key responsibilities include optimizing quality system processes, leading complex investigations, providing expertise in reliability engineering and process validation, representing the company during audits, collaborating with executive leadership, and mentoring other quality engineers.

Requirements

• Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
• 8+ years of progressively responsible quality experience in the medical device industry.
• Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
• Proven success leading cross-functional projects and influencing at senior levels.
• Advanced statistical analysis, risk management (ISO 14971).
• Track record of leading successful audits and remediation projects.
• Excellent verbal and written communication.
• Technical writing.
• Problem solving methodologies.
• Microsoft Office Suite.
• Quality Management System software.
• Investigations.
• Statistical techniques.

Nice To Haves

• Six Sigma Black Belt preferred.
• AATB or CTBS Certification, preferred.
• Lead Auditor Certification, preferred.
• ASQ – CQE, CBA, or CQA, preferred.

Responsibilities

• Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
• Own and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).
• Lead complex investigations and implement systemic corrective/preventive actions.
• Provide expertise in reliability engineering, process validation, and design for quality.
• Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.
• Collaborate with executive leadership to align quality strategies with business objectives.
• Mentor and coach quality engineers across multiple sites or functions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior