Senior QA Engineer – Contract to Hire

Location: NW Minneapolis Metro (On-site, 5 days/week)

About the Company

Our client is a medical device contract manufacturer (CDMO) supporting multiple OEM customers across active commercial and clinical programs. Their US-based quality team works across a diverse product portfolio, with manufacturing partners in Vietnam and Costa Rica. They operate with the pace and culture of a growth-stage organization – collaborative, solutions-oriented, and built on trust and accountability.
 

About the Role

This is position is supporting active commercial programs with a primary focus on customer complaint management. The role is closely tied to an electromechanical device portfolio that includes PCBAs, boards, vacuum pumps, and end-of-line testing. You will serve as the main point of contact for complaint activity tied to manufacturing sites in Vietnam and Costa Rica, managing the full cycle from intake through supplier corrective action and closure.

This is a hands-on, cross-functional role with direct interaction with customers, manufacturing engineering, and global site teams. The ideal candidate brings strong quality systems knowledge, solid complaint and NC experience, and the ability to work independently without waiting for direction.
 

Key Responsibilities

• Own the end-to-end customer complaint process, including intake, investigation, trending, and closure
• Monitor complaint ratios relative to overall sales by PO and lot number; escalate and flag trends proactively
• Issue and manage non-conformances (NCs) and supplier corrective action requests (CCARs) in collaboration with manufacturing and supplier teams
• Coordinate with Vietnam and Costa Rica site teams on open complaint activities and corrective actions – occasional early or late calls may be required to accommodate time zone differences
• Work with internal manufacturing engineers on follow-up required to resolve field issues
• Participate in regular customer-facing meetings, including change order reviews and weekly program touchpoints
• Navigate and execute within the company’s PLM and quality systems (Agile; transitioning to Propel)
• Apply working knowledge of electromechanical device characteristics (PCBAs, board assemblies, end-of-line testing) to evaluate and contextualize complaints

Required Qualifications

• Minimum 5 years of experience in a dedicated quality engineering or quality assurance role within a regulated medical device environment 
• Demonstrated experience managing customer complaints from intake through resolution, including NC and CCAR workflows
• Ability to interpret and apply quality systems, procedures, and regulatory requirements (ISO 13485, 21 CFR Part 820)
• Strong written and verbal communication skills; comfortable interfacing directly with customers and global site teams
• Comfortable working on-site 5 days per week; available for occasional off-hours calls to support Vietnam time zone alignment

Preferred Qualifications

• Background in electromechanical device manufacturing – PCBAs, board assemblies, vacuum systems, or end-of-line testing
• Experience within a CDMO or contract manufacturing environment
• Familiarity with Agile PLM or Propel
• Epicor experience
• Prior exposure to multi-site quality oversight (domestic and international manufacturing partners)

What They’re Looking for Beyond the Resume

This team moves fast, makes decisions, and holds each other accountable. There is an expectation for members of the team to identify problems, come in with potential solutions, and make calls even when it isn’t always comfortable. The ideal candidate is someone with a quiet confidence: decisive, adaptable, and genuinely invested in the team’s success. If you’ve come from an environment where you’ve had to figure things out without a lot of hand-holding, you’ll fit right in.
 

What This Role Is Not

• This is not a design assurance-heavy role – prior ops experience and an operations mindset is strongly preferred
• This is an on-site position; fully remote or hybrid arrangements are not available