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Sr. Validation Engineer, QA - Medical Device

  • Job type: Permanent
  • Location: Gainesville
  • Salary: $90000 - $105000 per annum
  • Job reference: MERZ04142018
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 14/04/2018
  • Medical Device – Orthopedic Implant Devices & Surgical Instrumentation
  • Gainesville, FL
  • $90k - $105k + Bonus + Benefits + Excellent Career Opportunity
A Medical Device company is urgently looking to hire a Senior Validation Engineer to take on responsibilities within the areas of Quality Assurance and Validation/Verification (V&V). This company is one of the global leaders for developing and marketing solutions for orthopedic implant devices and surgical instrumentation. They market their products globally and nationally to hospitals, clinics, surgeons, physicians, distributors, independent sales agencies, and direct sales representatives.

The Senior Validation Engineer, QA will be responsible for providing cross-functional support for Validation/Verification (V&V) planning, developing, and execution while maintaining the quality systems best practices, procedures, and policies.

The Senior Validation Engineer, Quality Assurance will be responsible for the following duties:
  • Participate in the execution and development of inspection and test methods regarding V&V projects
  • Provide hands-on and technical engineering assistance regarding V&V requirements for medical device equipment, processes, materials, and methods – Process Design, Project Management, critical process parameter development, document generation (IQ, OQ, PQ, SOPs), Protocol Execution & Summary Reports
  • Work closely with cross-functional teams in all aspects of device manufacturing and cleanliness V&V work – specification development, material testing, research, process capability studies, and investigation and process/test documentation
  • Maintain validation process auditing program within a timely manner
  • Apply Quality System, as well as Federal and International standards 

The Sr. Validation Engineer, QA will have the following requirements:
  • Bachelor’s Degree in within Life Sciences space
  • 7+ Years Medical Device industry experience 
  • Strong expertise writing IQ/OQ/PQ V&V protocols 
  • Risk Management, FDA, ISO regulations and V&V activities 
  • ASQ Certification preferred 

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