Senior Quality Engineer – Regenerative Medicine QA Lead

Rti Surgical Inc; Eden Prairie (MN); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

PTO

401(k) with company match

Holiday pay

Medical, dental, and vision insurance

Disability coverage

Job summary

Evergen in Eden Prairie, MN seeks a Senior Quality Engineer to lead quality initiatives across major design and manufacturing programs. You will own CAPA and QMS processes, guide investigations, and ensure compliance with FDA, ISO, and EU standards.

Collaboration with executives and mentoring of engineers are key aspects. The role requires 6+ years in medical device quality, strong statistical and risk-management skills, and willingness to travel up to 25% as needed.

Qualifications

• Bachelor’s or Master’s degree in engineering, life sciences, or a related discipline.
• 6+ years of quality experience in medical devices.
• Deep knowledge of FDA QSR, ISO 13485, EU MDR, MDSAP.
• Strong lead on cross-functional projects and senior stakeholder influence.
• ISO 14971 risk management and Six Sigma Black Belt preferred.

Responsibilities

• Lead quality efforts for major design and manufacturing projects with robust risk management.
• Own and optimize CAPA, supplier quality, complaint handling, and statistics in QMS.
• Direct complex investigations and drive systemic corrective actions.
• Provide expertise in reliability engineering and design for quality.
• Represent the company as a quality expert during FDA inspections and audits.
• Collaborate with executives to align quality with business objectives.
• Mentor and coach quality engineers across sites and functions.

Skills

Quality leadership

CAPA & QMS

Regulatory audits

Statistical methods

Reliability engineering

Process validation

Mentoring

Education

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

Job description

Evergen in Eden Prairie, MN seeks a Senior Quality Engineer to lead quality initiatives across major design and manufacturing programs. You will own CAPA and QMS processes, guide investigations, and ensure compliance with FDA, ISO, and EU standards.

Collaboration with executives and mentoring of engineers are key aspects. The role requires 6+ years in medical device quality, strong statistical and risk-management skills, and willingness to travel up to 25% as needed.