Evergen
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Staff Quality Engineer - (CONTRACTOR)
role at
Evergen
1 day ago - Be among the first 25 applicants
This range is provided by Evergen. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $130,000.00/yr - $145,000.00/yr
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.
Education Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
Experience 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), and Six Sigma Black Belt preferred. Track record of leading successful audits and remediation projects.
Certification AATB or CTBS Certification, preferred Lead Auditor Certification, preferred ASQ – CQE, CBA, or CQA, preferred
Skills Excellent verbal and written communication Technical writing Problem solving methodologies Microsoft Office Suite Quality Management System software Investigations Statistical techniques
Travel Up to 25% including international
Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment Onsite: Office environment with assigned workstation Remote positions only: Home office environment with minimum distractions
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:
Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
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.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Evergen by 2x
Get notified about new Staff Quality Engineer jobs in
Eden Prairie, MN .
#J-18808-Ljbffr
Staff Quality Engineer - (CONTRACTOR)
role at
Evergen
1 day ago - Be among the first 25 applicants
This range is provided by Evergen. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $130,000.00/yr - $145,000.00/yr
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.
Education Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
Experience 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), and Six Sigma Black Belt preferred. Track record of leading successful audits and remediation projects.
Certification AATB or CTBS Certification, preferred Lead Auditor Certification, preferred ASQ – CQE, CBA, or CQA, preferred
Skills Excellent verbal and written communication Technical writing Problem solving methodologies Microsoft Office Suite Quality Management System software Investigations Statistical techniques
Travel Up to 25% including international
Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment Onsite: Office environment with assigned workstation Remote positions only: Home office environment with minimum distractions
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:
Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
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.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Evergen by 2x
Get notified about new Staff Quality Engineer jobs in
Eden Prairie, MN .
#J-18808-Ljbffr