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Complaints Manager

Company: Thermo Fisher Scientific
Location: Pleasanton
Posted on: January 10, 2022

Job Description:

Job Title: Quality Manager, ComplaintsRequisition ID:When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.We're looking for an experienced leader with a strong background in Complaints Management for our Pleasanton facility which is part of the Genetic Science Division (GSD). This critical role will improve the current complaints process to drive results in our Quality function.Location/Division Specific InformationThis position will be located at our Pleasanton, CA facility.How will you make an impact?This position will be responsible for managing our 21CFR820, ISO 13485 and IVDR QMS Complaints process for all products where Pleasanton is the manufacturer of record which covers diagnostics medical device products and related equipment.What will you do?

  • Partner and collaborate with colleagues to seek opportunities and solutions related to complaint management to meet regulatory and quality compliance.
  • Manage, coach and develop the Complaints team to deliver outstanding results.
  • Ensure complaints are evaluated in a timely manner to ensure MDR and MDV compliance.
  • Ensure complaints are tracked and trended and escalated to CAPA when necessary.
  • Ensure complaints are investigated and closed in a timely manner.
  • Provide guidance to direct reports, peers and management in all areas of product complaints.
  • Support risk management and post market surveillance.
  • Promote and enable a culture of "right the first time."
  • Collaborate with leaders across the company to share resources and drive standard methodologies and tools.
  • Deliver monthly reporting on current performance and provide insights, regarding trends, risks and mitigation plans.
  • Support Management Reviews by presenting product complaint status.
  • Supervise and control department expenses within budget.How will you get here?
    • 7 years of demonstrated ability in Quality and/or Regulatory Affairs, with 5 of those in people management.
    • 5 years of experience with Complaint management in a 21CFR820 and ISO 13485 regulated company.Degree required and discipline
      • Bachelor's Degree in Engineering, Life Sciences or related subject area. Master's Degree a plus.
      • Strong background in complaint management in a regulated environment.Knowledge, Skills, Abilities
        • Technical expertise to analyze sophisticated product complaint data
        • Ability to make decisions while considering level of risks in regard to compliance, customer satisfaction and product quality.
        • Outstanding communication and problem-solving skills.
        • Keen attention to detail and ability to balance multiple tasks in a fast-paced environment.
        • Embodies the Thermo Fisher Scientific values of Integrity, Intensity, Involvement and Innovation.At Thermo Fisher Scientific, each one of our 70,000 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.Apply today! http://jobs.thermofisher.comThermo 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.

Keywords: Thermo Fisher Scientific, Pleasanton , Complaints Manager, Executive , Pleasanton, California

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