Quality Assurance Specialist
3 weeks ago
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.
- 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.
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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