Senior Quality Engineer: Medical Device Validation Leader

Aprios Custom MFG; Brooklyn Park (MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

ESOP

401(k) with company match

Health Reimbursement Account

Paid Time Off

Job summary

Aprios Custom MFG, a 100% employee-owned company, is seeking a Senior Quality Engineer to lead quality initiatives in medical device manufacturing, process validation, and injection molding. You will drive validation activities, support new product introductions, and mentor the team while ensuring product quality and compliance.

You will partner with customers to ensure successful commercialization, advance Lean Six Sigma, and strengthen quality systems across the organization.

Qualifications

• U.S. Citizen or Permanent Resident due to ITAR compliance requirements
• Bachelor's degree in mechanical or manufacturing engineering or related technical discipline
• 6–8+ years of progressive Quality Engineering experience in medical device manufacturing
• Experience with process validation, PPAP and quality systems in a regulated environment

Responsibilities

• Lead Voice of Quality during new product development and commercialization projects
• Collaborate with Manufacturing, Engineering, Tool Room, and PM teams to launch new products
• Design, execute, and approve complex validation protocols (OQ, PQ, PPQ) and maintain the Validation Master Plan
• Lead investigations (CAPA, NCMR, RMAs, customer complaints) and perform MSAs and Gage R&R studies
• Mentor Quality Inspectors and Metrology staff and support CMM/vision system activities

Skills

Quality Leadership

Medical Device

Process Validation

Injection Molding

Quality Systems

Statistical Analysis

Education

Mechanical Engineering

Manufacturing Engineering

Tools

CMMs

Vision Systems

IQMS/DelmiaWorks

Job description

Aprios Custom MFG, a 100% employee-owned company, is seeking a Senior Quality Engineer to lead quality initiatives in medical device manufacturing, process validation, and injection molding. You will drive validation activities, support new product introductions, and mentor the team while ensuring product quality and compliance.

You will partner with customers to ensure successful commercialization, advance Lean Six Sigma, and strengthen quality systems across the organization.