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Job ID :
45806BR
Location :
US - Michigan - Kalamazoo
:
Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. 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. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.


Position Summary:

This position coordinates the Quality Management system ensuring compliance to all relevant regulations and standards including ISO13485 and FDA QSR Part 820. This includes change management, record retention, training, and leading the internal audit program.

  • Establish and maintain procedures to control all documents and records.
  • Ensure compliance with record retention per corporate policy. Maintain offsite records storage and organization. Prepare records for destruction.
  • Drive continual improvement through all elements of the Quality Management System.
  • Internal Audits: Lead the internal audit program by developing and maintaining the internal audit schedule, coordinating training to ensure adequate internal auditors and lead auditors are available, ensuring adherence to schedule, and ensuring all findings receive proper follow up and closure.
  • Establish and maintain procedures to control labeling activities including label creation, change control, and linkages to associated documents,
  • Establish and maintain procedures for change control, including development and implementation of engineering change control process, label change control process, and process change control procedures. This includes the creation, development, implementation, training, and maintenance of an electronic change control system.
  • Support third party audits or investigations.
  • Ensure regulations and standards are available and up to date.
  • Maintain device master files.
  • Maintain internal / external audit schedule, conduct audits and track action item closure and effectiveness per ISO 13485.
  • Provide training to the organization in QSR, ISO 13485 and proper procedures as required.
  • Lead and participate on Practical Process Improvement teams.
  • Develop appropriate training when processes have been revised, maintain electronic training records
  • Review and write/revise Quality Systems SOP’s on a continuous basis to support continual improvement.
  • Lead cross functional teams to improve processes and associated procedures.
  • Maintain compliance with all company policies and procedures (safety, regulatory, etc.).
  • IQ/OQ and Service Report review for completion and filing

Minimum Requirements/Qualifications:

  • Bachelor’s degree
  • Quality Systems Regulations experience required
  • Experience in a manufacturing environment
  • Proficient in MS applications (Excel, Word, Outlook)
  • Excellent communication and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
  • Familiarity with Quality Systems Regulations
  • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
  • Creative, analytical problem solving skills
  • Ability to handle critical timelines in a multi-task environment
  • ISO 13485 Internal Auditor Certification preferred
  • Experience with Master Control as a Document Management tool

Non-Negotiable Hiring Criteria:

  • Bachelor’s degree
  • Ability to handle critical timelines in a multi-task environment
  • Familiarity with Quality Systems Regulations and ISO13485
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude



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.
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