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Thermo Fisher Scientific logo
Company Name:
Thermo Fisher Scientific
Approximate Salary:
Not Specified
Kalamazoo, MI
United States
Position type:
Experience level:
Education level:

Division Compliance Manager - IVD

Job Description

As the world s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

The Anatomical Pathology Division (APD) offers a complete line of anatomical pathology instruments and consumables from specimen collection to diagnosis. Product reach is mainly to Pathology labs in a hospital setting, but also used in independent labs and the research and academia markets. APD`s collaborative team of employees are delivering critical answers and strive to provide Pathology labs a more efficient, safe and productive environment. The group has it s headquarter in Portsmouth NH, with manufacturing sites domestically in Kalamazoo, MI and Portsmouth, NH.

This position can be based in Kalamazoo Michigan, Portsmouth New Hampshire, Solon Ohio, Pittsburgh Pennsylvania

Position Summary:

This position leads the APD Compliance Management and associated performance monitoring process, performing quality assessments and audits as required. Working with Sourcing, Manufacturing, Engineering, Quality and others to implement and maintain UDI/GS1, drive Import/Export Compliance, support Engineering and manufacturing on Reach/ROHS compliance and serve as a Division Auditor.

  • Lead the UDI Class I and GS1 implementation initiative
  • Lead Import/Export Compliance and maintenance
  • Support ROHS/Reach Compliance
  • Lead Division Internal Auditing activities.
  • Develop Division SOPs
  • Ensure the timely input of required performance data/metrics from APD
  • Provide compliance support for projects helping to achieve site, Business Unit, Division and company goals.
  • Establish effective working links with other Thermo Fisher professionals in order to improve processes and compliance.
  • Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management
Minimum Requirements:
  • Bachelor s Degree
  • 2 plus years of Medical Device/IVD project management experience
  • Experience of working with Medical Device/IVD regulated products (ISO13485/ FDA QSR Part 820 requirements)
Preferred Requirements:
  • Experience & qualification/ certification in internal auditing, preferably as a lead auditor
  • UDI Experience
  • ROHS/Reach Compliance experience
  • Import/Export Compliance experience
  • Product Management experience
  • Experience of working with cross functional teams
  • Knowledge of quality investigation and improvement tools, (8D, cause & effect, FMEA, 5Whys etc.)
  • Excellent interpersonal and communication skills both written & oral
  • Ability to work in a timeline driven environment
  • Excellent Microsoft skills
  • Up to 50% travel Globally

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Associated topics: editor in chief, fire marshal, general manager, gerente, lieutenant, petty officer, shift lead, shift supervisor, supervisor, team lead

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