Accessibility Links

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 

Similar jobs
Quality Assurance Validation Manager
  • Job type: Permanent
  • Location: Charlotte, North Carolina
  • Salary: Targetted Bonus + Excellent Benefits
  • Description Quality Assurance Validation Manager North Carolina Excellent Salary + excellent bonus + excellent benefits An innovative research-based global pharmaceutical company is seeking a QA Validation
CSV Engineer
  • Job type: Contract
  • Location: Cambridge, Massachusetts
  • Salary: Negotiable
  • Description EPM Scientific is partnering up with an exciting g industry leader who is looking t expand their CSV team. Do to resent growth and the beginning of new projects, they are seeking a CSV engineer who
Sr. Director GCP Compliance
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Sr. Director GCP Compliance San Francisco Bay Area Excellent Salary + excellent bonus + excellent benefits + Equity Do you want to be rewarded for the hard work you put into to your work on a
Director, Site Quality Operations
  • Job type: Permanent
  • Location: New York
  • Salary: Negotiable
  • Description Director, Site Quality Operations New York Excellent Salary + excellent bonus + excellent benefits + Stock Have you ever wanted to join a company where you have the resources of a large company
Sr. Director, Site Quality Head
  • Job type: Permanent
  • Location: Cincinnati, Ohio
  • Salary: Negotiable
  • Description Sr. Director, Site Quality Head Greater Cincinnati, OH area A large global leader in pharmaceuticals is looking for Sr. Director, Site Quality Head to join their rapidly expanding team! This company