Quality Engineer

Quality Engineer - Field CAPA & Design Quality

Location: Arden Hills, MN (4 days onsite / 1 remote)

Contract: 12 months | Pay Rate: $55-$58/hr. | Schedule: 8:00 AM - 4:30 PM

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

We are seeking a highly skilled Quality Engineer to lead cross-functional teams in investigating complex product performance issues for Active Implantable & Accessories within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role requires a technical, collaborative, and project-focused individual capable of guiding teams to actionable solutions.

Key Responsibilities:

• Lead cross-functional teams on product performance investigations, CAPAs, NCEPs, and Field Action recommendations.
• Apply disciplined problem-solving methods including DMAIC, Root Cause Analysis, 5 Whys, and Cause & Effect diagrams.
• Partner with R&D, Regulatory, Medical Safety, Manufacturing, and other Quality groups to resolve technical product issues.
• Create, review, and approve quality system records and maintain detailed documentation per Good Documentation Practices.
• Mentor and guide engineers and teams on CAPA execution, continuous improvement, and compliance with quality standards.
• Present updates to senior leadership, divisional teams, and stakeholders.
• Ensure all work aligns with company policies, procedures, and regulatory compliance with a focus on patient safety.

Qualifications:

• Bachelor's degree in Engineering or related discipline with 4+ years of relevant experience.
• Strong technical problem-solving and analytical skills.
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485 standards.
• Experience with CAPAs, Field Actions, non-conformance investigations, and medical device quality processes.
• Proficient with Microsoft Office.

Preferred:

• Active Implantable product experience, statistical analysis skills, and project management expertise.
• Ability to lead cross-functional teams across software, firmware, hardware, and mechanical disciplines.

Guide teams to deliver effective solutions for high-visibility medical devices. Click "Apply Now" to join the team.

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