Quality Engineer

Quality Engineer Advantage Technical $55.00•58.00 paid holidays, 401(k) Apr 08, 2026 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. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. About Us Advantage Technical connects top•talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.