Staff Quality Engineer - (CONTRACTOR)

Job Description

Job Description

This is a hybrid contractor role supporting both the Eden Prairie, MN, and Glasgow, UK, sites.

RTI Surgical is now Evergen!

This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

Read more about this change and Evergen’s commitment to advancing regenerative medicine here : https : / / lnkd.in / eMSfVJkM

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.

REQUIREMENTS

Education

Experience

Certification

Skills

Travel

SAFETY

Physical Requirement

75%) stationary position (standing or sitting) while utilizing digital displays

75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

More about Evergen :

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values :

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

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