Senior Quality Assurance Systems Specialist

2 weeks ago


Reno, Nevada, United States Revvity Full time

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
Basic Qualifications:
  • 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
Preferred Qualifications:
  • 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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