Senior Validation Engineer Medical Device

Warsaw Area, IN

Posted: 03/13/2019 Industry: Medical Device Job Number: 2704 Pay Rate: $85,000-$105,000

Senior Validation Engineer Medical Device

Great companies are always looking to improve process and enhance outcomes. Our client is adding Senior Validation Engineer to the team.

This opportunity is a career launching position with an industry leader! If you are a problem solver with self starter DNA this is your next opportunity!

Our client manufactures medical implants for the orthopedic and dental markets. They are a world-wide leader in design and delivery in this marketplace.

This is a critical fill and interviews will be scheduled immediately. Those chosen will have competitive salaries, bonus, solid benefits including healthcare, 401k, relocation assistance, and more. This client promotes from within and recognizes those who do their jobs well.

Responsibilities:

  • Managing CAPA’s and interfacing with the FDA
  • Continuous improvement in processes.
  • Communications to upper management
  • Conducts Management Review process in accordance with ISO standards.
  • Working knowledge of standards and regulations ISO 13485, FDA 21 CFR Part 820
  • Understanding of IO/OQ/PQ
  • Able to interpret technical drawings, blueprints, specifications, illustrations, and written documents
  • Validation representative for audits requirements (FDA, ISO)

 

Requirements:

  • BS in Engineering Mechanical, Industrial, Biomedical
  • 5+ years in medical device or pharma (sterility assurance a plus)
  • Regulatory Compliance experience ISO13485 IQ/OQ/PQ
  • Documenting and reporting the analysis of test results
  • CAPA experience
  • CAPA explanation to FDA
  • Problem solver with strong written and verbal communication
  • Provide critical analysis to upper management
  • Review SOP’s and recommend improvements
  • Troubleshooting in the event of abnormal testing results
  • Experience standards and regulations ISO 13485, FDA 21 CFR Part 820 also acceptable experience with ISO 11135, ISO 17665, ISO 11137, ISO 14644,
  • Strong computer skills, including the MS Office suite and MS Project.
  • Interpret technical drawings, blueprints, specifications, illustrations, and written documents
  • Detail oriented, self-motivated and a team player

Nice to Have:

  • Experience in high value metals CNC environment
  • Expertise in one or more CNC, Finishing, cleaning, cell design, heat treatment, casting, forging

 

Paula Morisey
Research & Recruitment Specialist

Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.

With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.

Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.

Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.

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