Senior Quality Engineer

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

Lead Quality Excellence in a 100% Employee-Owned Company

At Aprios Custom MFG, we're passionate about delivering high-quality custom plastic injection molded and medical assembly solutions to our customers. As a 100% employee-owned company, every team member contributes directly to our success and shares in our growth.

We are seeking an experienced Senior Quality Engineer to serve as a technical leader within our Quality Department. This role is ideal for a hands‑on quality professional with deep expertise in medical device manufacturing, process validation, injection molding, and quality systems. You'll play a critical role in driving quality excellence, supporting new product introductions, leading validation efforts, mentoring team members, and partnering with customers to ensure successful product commercialization.

What You'll Do

• Serve as the Voice of Quality during new product development and commercialization projects
• Partner with Manufacturing, Engineering, Tool Room, and Project Management teams to launch new products successfully
• Design, execute, and approve complex validation protocols, including:
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• PPQ (Process Performance Qualification)
• Maintain and manage the site's Validation Master Plan (VMP)
• Define revalidation requirements related to tooling, material, or process changes
• Lead quality implementation efforts for customer‑designed products from prototyping through production launch

Quality Systems & Technical Leadership

• Lead investigations involving:
• Customer Complaints
• CAPAs
• RMAs
• Non‑Conforming Material Reports (NCMRs)
• Utilize advanced problem‑solving methodologies including:
• 8D
• 5 Whys
• Fishbone Analysis
• Conduct Measurement System Analysis (MSA) and Gage R&R studies
• Perform statistical capability analysis (Cpk/Ppk)
• Develop and approve inspection plans, quality procedures, and work instructions
• Provide technical guidance to Quality Inspectors and Metrology personnel
• Support advanced metrology activities including CMM and vision system applications

Compliance, Risk Management & Continuous Improvement

• Serve as an internal auditor and support customer and third‑party audits
• Ensure compliance with:
• ISO 13485
• ISO 9001
• FDA 21 CFR Part 820
• Lead Risk Management efforts including:
• PFMEA
• Drive Lean Six Sigma and continuous improvement initiatives
• Analyze defect trends and implement corrective actions to reduce scrap and improve efficiency

What We're Looking For

Required Qualifications

• U.S. Citizen or Permanent Resident (Green Card Holder) due to ITAR compliance requirements
• Bachelor's Degree in:
• Mechanical Engineering
• Manufacturing Engineering
• Or a related technical discipline
• 6‑8+ years of progressive Quality Engineering experience
• Medical Device manufacturing experience required
• Strong background in:
• Scientific Molding
• Tool Qualification
• Process Validation

Technical Expertise

• Expert knowledge of:
• PPAP
• ISO 13485
• FDA Validation Requirements
• PFMEA
• CAPA Systems
• Strong understanding of GD&T and engineering drawings
• Experience with:
• CMMs
• Vision Systems
• Precision Measurement Equipment
• Advanced proficiency with:
• Microsoft Office
• Minitab
• IQMS/DelmiaWorks or similar QMS/ERP systems

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt or Black Belt
• Excellent written and verbal communication skills
• Experience presenting technical information to customers, auditors, and executive leadership
• Ability to mentor junior engineers and quality personnel
• Strong decision‑making and problem‑solving capabilities
• Proven ability to lead cross‑functional teams in a fast‑paced manufacturing environment

Physical Requirements

• Ability to work in both office and production floor environments
• Frequent interaction with manufacturing operations and production teams
• Ability to sit or stand for extended periods
• Ability to occasionally lift up to 35 pounds
• Up to 10% travel for customer visits, supplier audits, and specialized training
• 100% Employee‑Owned Company (ESOP)
• 401(k) with Company Match
• Health Reimbursement Account (HRA)
• Paid Time Off (PTO)
• Opportunity to influence quality strategy and operational excellence
• Collaborative, team‑oriented culture
• Professional development and advancement opportunities
• Exposure to innovative medical and industrial manufacturing projects

Apply Today

If you're a motivated quality leader with expertise in medical device manufacturing, process validation, and plastic injection molding, we invite you to join Aprios Custom MFG and help drive quality excellence across our organization.

Aprios Custom MFG is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace.