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Division Compliance Manager - IVD

Company name
Thermo Fisher Scientific Inc.

Location
Kalamazoo, MI

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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.

Company info

Thermo Fisher Scientific Inc.
Website : http://www.thermofisher.com

Company Profile
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

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