Principal Quality Engineer
Listed on 2026-02-16
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Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Overview
Join a medical device company looking for a Sr. or Pr. Quality Engineer to lead and innovate the quality assurance processes of their electromechanical device unit. This would be an onsite position in the NW Twin Cities metro.
Responsibilities- Lead quality strategy across product development, manufacturing, and supply chain operations.
- Own and maintain the QMS, ensuring compliance with ISO 13485, FDA, and global regulatory standards.
- Drive proactive risk management and continuous improvement through FMEAs, investigations, and CAPAs.
- Collaborate with engineering, manufacturing, and suppliers to enhance quality performance.
- Mentor teams and represent Quality during regulatory audits and inspections.
- Minimum of 8 years of experience (for Principal) or 5 years of experience (for Senior) in medical device quality engineering
- Strong understanding of quality management systems (QMS) and regulatory requirements, including ISO 13485
- Experience with root cause investigation and managing NCMR/CAPAs
- Author and execute test method validation and design for manufacturability
- Experience with inspections, master validation plans, and process validations (IQ/OQ/PQ)
- Must have experience with electromechanical devices
- Compensation package of up to $160k + profit sharing for Principal
- Compensation package of up to $125k + profit sharing for Senior
- Ability to contribute to work on meaningful products with a global impact in stable organization
- Environment with highly skilled engineers that value work life balance
- Opportunity to foster a culture of quality across the organization by establishing standards and practices that support regulatory compliance and product excellence
EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
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