Senior Quality Engineer

Position Overview

Senior Quality Engineer

Location: Brooklyn Park, MN
Job Type: Full-Time

Aprios Custom MFG, a 100% employee-owned custom plastics manufacturer, is seeking an experienced Senior Quality Engineer to lead quality initiatives supporting medical device and industrial manufacturing programs. This role is responsible for new product introductions, process validation, regulatory compliance, customer quality support, and continuous improvement efforts.

Responsibilities

• Lead quality support for new product introductions and commercialization projects
• Develop and execute IQ, OQ, PQ, and PPQ validation protocols
• Drive CAPA investigations, root cause analysis, and corrective actions
• Support ISO 13485, ISO 9001, and FDA compliance requirements
• Lead PFMEAs, risk assessments, and control plan development
• Analyze process capability and measurement systems (MSA/Gage R&R)
• Support customer, supplier, and regulatory audits
• Mentor junior quality team members and provide technical leadership

Qualifications

• Bachelor's degree in Engineering or related technical field
• 6+ years of Quality Engineering experience in a regulated manufacturing environment
• Medical device manufacturing experience required
• Strong background in plastic injection molding and process validation
• Knowledge of ISO 13485, FDA 21 CFR Part 820, PPAP, CAPA, and PFMEA
• Experience with Minitab, ERP/QMS systems, and statistical analysis
• Strong communication, leadership, and problem-solving skills

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt or Black Belt
• ISO 13485 Lead Auditor certification

Benefits

• Employee Stock Ownership Plan (ESOP)
• 401(k) with company match
• Health insurance and Health Reimbursement Account (HRA)
• Paid Time Off (PTO)
• Career growth opportunities

Applicants must be U.S. Citizens or Permanent Residents due to ITAR compliance requirements.

Join Aprios Custom MFG and help drive quality excellence in an employee-owned company committed to innovation, precision, and continuous improvement.

Aprios Custom MFG is an Equal Opportunity Employer.