Senior Quality Assurance Specialist
21 hours ago
We are seeking an experienced Senior Quality Assurance Specialist to join our team in Mansfield, MA. This role will focus on ensuring the quality and integrity of our products and processes, while providing leadership and guidance to other engineers and technicians.
The ideal candidate will have a strong background in quality management systems, with experience working in manufacturing operations and implementing risk management strategies. They should be proficient in auditing and process improvement, with a proven track record of implementing effective mitigation plans.
Key Responsibilities:
* Utilize risk management principles to prevent unanticipated failure modes and improve process capability
* Develop and implement process monitoring and control methods consistent with process/product risk
* Conduct internal and supplier audits to ensure compliance with ISO-13485 and 21CFR820 standards
Requirements:
* Bachelor's degree or equivalent with 8+ years of experience, master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience
* Minimum 5 years of experience working in manufacturing/operations
* Strong knowledge of product/process risk management (FDA and ISO standards)
* Experience with internal audit to ISO-13485 certification
Salary: $45-$60 per hour
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