E
Senior Quality Engineer - (CONTRACTOR)
Accepting applicationsEvergen · Eden Prairie, MN
Full-Time Senior Mentoraiategansic
Posted
7 May
Category
Test
Experience
Senior
Country
United States
Location: Eden Prairie, MN (100% Onsite)
This is a full-time contractor role supporting our Eden Prairie, MN site.
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
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
SAFETY
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.
Show more Show less
This is a full-time contractor role supporting our Eden Prairie, MN site.
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
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
SAFETY
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.
Show more Show less