Senior Quality Engineer

RiseMe; Eden Prairie (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid Time Off (PTO)

401(k) match

Holiday pay

Health insurance

Disability coverage

Parental leave

Job summary

Evergen in Eden Prairie, MN is seeking a Quality Lead to own design and manufacturing quality programs. You will ensure robust risk management, compliance with FDA QSR, ISO 13485, EU MDR, and lead cross-functional projects across sites.

The role requires 6+ years in medical device quality, advanced statistics, CAPA, supplier quality, and audits. Expect collaboration with executives, mentoring engineers, and occasional international travel up to 25%.

Qualifications

• 6+ years of quality experience in the medical device industry.
• Deep knowledge of FDA QSR, ISO 13485, EU MDR, MDSAP.
• Proven success leading cross-functional projects and influencing at senior levels.
• Advanced statistical analysis and ISO 14971 risk management; Six Sigma Black Belt preferred.
• Track record of leading audits and remediation projects.

Responsibilities

• Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
• Own and optimize quality system processes (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.

Skills

Communication

Technical writing

Problem solving

Microsoft Office

QMS software

Investigations

Statistical methods

Education

Bachelor’s or Master’s degree in engineering, life sciences, or related discipline

Job description

Location:Eden Prairie, MN

Annual CIP bonus opportunity of up to $10,000.00

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, Germany; Glasgow, UK; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

Our comprehensive benefits package includes:

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Paid parental leave and much more!

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://www.linkedin.com/company/evergenbio

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

• 6+ 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.