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Sr. Quality Engineer

Kenosha, Wisconsin Permanent USD80,000 - USD100,000 per year View Job Description
This is a senior-level Quality Engineering role with a medical device manufacturer located near the Illinois-Wisconsin border. The position is responsible for leading and supporting all quality assurance and quality control activities within a metal fabrication manufacturing environment.
  • Strong Medical Device Company
  • Competitive salary and benefits

About Our Client

Our client is a recognized leader in medical device manufacturing, supplying advanced solutions to numerous major OEM partners. Their capabilities span a wide range of metal-fabricated products, including designs incorporating silicone handle applications. The company produces precision components and devices used in surgical implants, robotic systems, orthopaedic applications, and other critical medical technologies.

Job Description

  • Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards
  • Investigate and address customer complaints - CAPA
  • Assist with preparing and executing internal and external audits
  • Handle document and process controls
  • Update documentation and data within the QMS
  • Create and direct validations (IQ/OQ/PQ)
  • Create PPAP documentation
  • Other duties as assigned

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • 5-7+ years of quality experience in medical device
  • understanding of ISO13485 and FDA standards
  • Experience with metal fabrication, CNC preferred
  • GD&T/PPAP experience
  • Knowledge of QMS software and associated document control
  • Certifications a plus
  • Bachelors degree a plus
  • Sponsorship NOT offered

What's on Offer

  • Salary ranging from 80,000-100,000+ depending on experience and interviews
  • 3 weeks of PTO- accrues from day one
  • Full medical benefit plans offered on day one
  • Ancillary benefits
  • Company paid holidays
  • Retirement plans offered
Contact
Max Sinton
Quote job ref
JN-122025-6906343

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
Kenosha
Contract Type
Permanent
Consultant name
Max Sinton
Job Reference
JN-122025-6906343