Quality Engineer

Reprise Biomedical, Inc. is seeking a Quality Engineer to join our growing team as we develop and commercialize biological medical devices that provide advanced solutions for healing complex wounds. We are a growth-oriented and innovation-focused organization, offering opportunities to contribute directly to life-improving medical technologies.

This role will work full-time, on-site at our home office in Plymouth, MN playing a key role in ensuring our products meet the highest standards of safety, compliance, and performance. You will work closely with cross-functional teams to support design, manufacturing, and post-market activities in accordance with FDA, ISO 13485, and other regulatory requirements.

Qualified candidates will have:

• A bachelor’s degree in Engineering, Quality, or related field (or equivalent experience)
• Strong knowledge of quality management systems and regulatory requirements
• Experience with risk management (ISO 14971) and statistical analysis tools
• Excellent problem-solving, communication, and documentation skills

In addition, we are seeking candidates with the following preferred qualifications:

• 2–5 years of quality engineering experience in the medical device industry
• ASQ Certified Quality Engineer (CQE) or equivalent certification
• ISO 13485 Lead Auditor
• Experience with design for manufacturability and process validation

Key responsibilities include:

• Conducting risk assessments, root cause investigations, and corrective/preventive actions (CAPA)
• Supporting design control activities, including verification and validation testing
• Performing supplier quality audits and managing nonconformance reports
• Ensuring compliance with FDA 21 CFR Part 820 and ISO 13485
• Collaborating with R&D, manufacturing, and regulatory teams to drive continuous improvement

The compensation range of $65,000 to $90,000 represents a good faith estimate of what we expect to pay for the role based on current market conditions, the responsibilities of the position, and the qualifications of the ideal candidate. While we strive to offer competitive compensation, it is important to note that offers are typically made within the range but not at the top.

The final offer will be determined based on the candidate’s skills, experience, and other relevant factors.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are unable to sponsor visas both currently and in the future.

Relocation assistance will not be provided for this role.