Senior Quality Control Engineer Job at Insight Global, Arden Hills, MN

SWE4b1dkNFFLbjZ1RUFDQ3RpdXZ6OFVTNHc9PQ==
  • Insight Global
  • Arden Hills, MN

Job Description

Compensation:

$108k-$115k per year annual salary. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role may include healthcare

insurance offerings and paid leave as provided by applicable law.

Job Description:

In this role, responsibilities include maintaining and supporting medical electrical equipment electrophysiology recording systems and RF therapy capital equipment. Include managing change notices, monitoring post-market product performance, implementing product modifications, and ensuring nonconformance and CAPA compliance. Actively participate in various forums, standards councils, and cross-functional teams to support coordination across different geographic regions. Responsible for maintaining legacy products, supporting post-market reporting (PMVP, PMVR, PMSR), and managing Quality System deviations. Led audit support, NCEP/CAPA processes, and quality tracking across complex, multi-site environments. Applied systematic problem-solving, mentored teams, and drove process improvements aligned with VIP and Continuous Improvement goals. Knowledgeable in End-of-Life processes and regulatory standards. Reviews authors change notices quality records potential audits and participation in lab experiments with R&D and the ability to present technical subjects (design perspectives) to directors and VP's.

Must haves:

  • Bachelor's degree in electrical engineering, mechanical engineering, computer engineering, biomedical engineering, physics, or aerospace
  • 3+ years of experience with design assurance/ quality and sustaining or R&D engineering
  • Medical device CAPA capital equipment experience
  • Interested in someone that works with it that the company makes that’s bought by a customer

Nice to have skills and experiences:

  • Experience with standards specifically IEC 60601
  • Experience with medical standards for compliance including ISO 13485, ISO 14971 and FDA quality system regulations, specifically focused on design controls
  • Experience in post market quality CAPA's (corrective and preventative action)
  • Experience in design engineering, process development and continuation engineering

Job Tags

Similar Jobs

Savannah College of Art and Design

Professor, Advertising and Branding Job at Savannah College of Art and Design

 ...SCAD Savannah is seeking a visionary full-time professor of advertising and branding who can empower students to revolutionize the future of advertising through creative technology and design. This role is at the forefront of the industry, shaping the next generation of... 

Marquis Home Care

HOME HEALTH AIDES AND PERSONAL CARE AIDES NEEDED Job at Marquis Home Care

 ...Home Health Aide or Personal Care Aide Overview: Seeking individuals who are interested in joining our team. We provide home care in the community and provide care at our local Assisted Living Facilities. Choose which one suits you best! We also provide FREE training to... 

Comprehensive EyeCare Partners

Vitreoretinal Surgeon Job at Comprehensive EyeCare Partners

 ...Comprehensive EyeCare Partners, in partnership with Texan Eye , has an amazing opportunity for a Retina Surgeon to join this renowned practice in Austin, Texas! Why move to Austin? Austin has quickly emerged as one of the most sought-after cities to relocate to in recent... 

Delta Electronics Americas

Employment Counsel Job at Delta Electronics Americas

Employment Counsel Delta Electronics Americas Company and BG Description : Founded in 1971, Delta Group is the global leader in power and thermal management solutions. Our mission statement, To provide innovative, clean and energy-efficient solutions for a better...

Elegant Enterprise-Wide Solutions, Inc.

Curam QA Tester (W2 Only) Job at Elegant Enterprise-Wide Solutions, Inc.

 ...About this Position: Job Title: Curam QA Tester DAILY DUTIES / RESPONSIBILITIES: Responsible for performing tests on technical solutions to isolate and solve issues. Initiates tests, analyzes results, and finds solutions to technical problems. Develop test...