Quality Assurance Specialist

3 weeks ago


Milwaukee, Wisconsin, United States Michael Page Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team in Milwaukee. As a key member of our Quality department, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest level of product quality.

The ideal candidate will have a strong background in quality engineering and experience working in a manufacturing environment. You will be responsible for leading customer communication, root cause/corrective actions, and implementing process improvements to increase efficiency.

Key Responsibilities
  • Supporting regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Implementing various product and process improvement methodologies to enhance quality and efficiency.
  • Reviewing and validating changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.
  • Leading risk analysis and developing protocols and reports for test method validations.
  • Collaborating with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
  • Developing inspection techniques and procedures to ensure product integrity to design specifications.
Requirements
  • A Bachelor's Degree in an engineering-related field.
  • 4+ years of experience in a manufacturing environment, specifically in metal working or machining.
  • Project Management and Lean Manufacturing experience.
  • Strong knowledge of statistical tools and Design of Experiments (DOE).
  • Excellent communication and interpersonal skills.
  • Working knowledge of ISO 9001:2015, ISO 13485:2015, 21 CFR, and cGMPs.
What We Offer

We offer a competitive base salary of $85,000 - $95,000 per year, depending on experience and skills. Additionally, we provide:

  • Bonus opportunity up to 5%.
  • Comprehensive benefits package including Medical, Dental, and Vision.
  • Medical/Prescription Drug Coverage - 3 Blue Cross Option (2 PPOs, 1 HDHP).
  • Health Savings Account and Flexible Spending Accounts.
  • Dental Coverage - 2 Met Life Options.
  • Life and AD&D Coverage.
  • Short-term disability coverage.
  • 15 PTO Days + 10 holidays.
  • 401(k) with 3% company match.


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