Senior Quality Assurance Systems Specialist
2 weeks ago
Senior Quality Systems Specialist
Revvity is actively looking for a Senior Quality Systems Specialist to enhance our Quality Management team. In this pivotal role, you will spearhead the evolution of our quality management framework. The ideal candidate will possess a Bachelor's Degree in a Life Sciences field and a minimum of 5 years of expertise in Quality Systems, ideally within the Medical Device or Clinical Laboratory sectors.
Key Responsibilities:- Ensure adherence to all organizational policies, procedures, and regulatory standards
- Oversee the maintenance of the Quality Management System
- Facilitate QM training initiatives and mentor team members
- Engage in both internal and external quality assessments
- Manage issues related to non-conforming and returned products
- Collaborate with various departments to uphold quality compliance
- Assist in the preparation of essential compliance documentation
- Analyze and present pertinent data to management
- Bachelor's Degree in a Life Sciences discipline
- 5 years of experience in Quality Systems within the Medical Device or Clinical Laboratory field
- Familiarity with ISO 13485 and 21 CFR Part 820 standards
- Proficiency in CAPA resolution processes
- Capability to draft Technical Documents
- Experience with MDSAP Audit Approach
- Understanding of Lean and Six Sigma principles
- Meticulous attention to detail and proficiency in writing SOPs and technical documentation
- Highly organized with the ability to work autonomously
- Excellent communication skills and a proactive approach
What We Offer:
We provide a comprehensive benefits package that includes medical, dental, and vision coverage, life and disability insurance, paid time off, parental leave, a 401k plan with company matching, and an Employee Stock Purchase Plan.
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