Senior Quality Engineer

Aprios - Diversified Plastics, Inc. • Minneapolis, MN

9d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior