Senior Quality Engineer (Medical Devices)

Location: Onsite in St. Paul, Minnesota, United States. Work includes office, production, laboratory, warehouse, and occasional clean room environments with required PPE.

Salary: $96,000–$132,000 annually, with potential discretionary bonuses.

Company

Healthcare company focused on developing and delivering products that help save and sustain lives.

What you will do

• Provide quality engineering support for manufacturing operations, including nonconformances, CAPA, change controls, validation reviews, and production issues.
• Lead investigations into nonconforming products, customer complaints, process deviations, supplier quality issues, and quality system events using root cause analysis.
• Represent Quality Engineering on cross-functional manufacturing, product development, validation, process improvement, and sustaining engineering teams.
• Support supplier manufacturing processes, including injection molding validation, process capability analysis, tooling changes, monitoring, and continuous improvement.
• Review and approve change controls, validation protocols and reports, specifications, procedures, risk assessments, and engineering studies.
• Lead risk management, audits, quality improvement projects, governance forums, and regulatory compliance activities while mentoring junior Quality Engineers.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field.
• At least 3 years of Quality Engineering experience in a regulated medical device, pharmaceutical, biologics, or combination product environment.
• Knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, cGMP requirements, and validation principles.
• Experience with CAPA, nonconformance management, complaint handling, change control, supplier quality, auditing, validation, and regulated manufacturing processes.
• Strong analytical, problem-solving, risk-based decision-making, presentation, facilitation, and communication skills.
• Applicants must be authorized to work for any employer in the United States.

Culture & Benefits

• Onsite work with time divided among office, production, laboratory, warehouse, and clean room areas.
• Medical and dental coverage begins on day one for eligible roles, along with life, disability, and travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, employee discounts, and employee assistance programs.