Quality Assurance Specialist

21 hours ago


Elgin, Illinois, United States Michael Page Full time
About Our Client

A leading medical device manufacturer in the Western Suburbs of Chicago is seeking a Quality Assurance Engineer to enhance their expanding Quality team.

Job Description

Key Responsibilities:

  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Leads and implements various product and process improvement methodologies.
  • Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Leads in the completion and maintenance of risk analysis.
  • Leads generation and completion of protocols and reports for test method validations.
  • Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
  • Recommends process monitoring devices where applicable.
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications.
  • Responsible for the writing, approval, and implementation of Incoming, In-Process, and Final Inspection procedures.
  • Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Requirements
  • Relevant Quality Assurance Engineering Experience
  • Bachelor's Degree (Science Related)
  • 3+ years of experience in a Cleanroom environment
  • Strong Medical Device Manufacturing Experience
  • Good knowledge of statistical tools and appropriate use of Design of Experiments (DOE) when developing recommendations
  • Excellent communication and interpersonal skills
  • Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs
What's on Offer
  • Competitive base salary between $80,000-$95,000, depending on experience and skills
  • Bonus opportunity up to 5%
  • Comprehensive benefits package including Medical, Dental, and Vision
  • Life and AD&D Coverage
  • Short-term disability coverage
  • 15 PTO Days + 10 holidays
  • 401(k) with 6% company match


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