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Thermo Fisher Scientific Quality Systems Manager in Rochester, New York

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. You’ll have the opportunity to grow and learn in a culture that empowers your development. We have created an inclusive, global environment that values the power of diverse talent, backgrounds, and experiences to drive speed, productivity, innovation, and growth.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. With revenues of $20 billion and the largest investment in R&D in the industry, we give our 70,000 employees the resources and opportunities to make significant contributions to the world. The customers we serve fall within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies. Our products and services help accelerate the pace of scientific discovery, and solve challenges ranging from complex research to routine testing to field applications.

Job Summary

We are looking for a self-driven, resourceful Quality Systems Manager with up-to-date knowledge, and demonstrated experience driving and sustaining improvement to the Quality Management System to ensure compliance to FDA Quality System Regulations (21 CFR Part 820), ISO 13485 ISO 9001, ISO 14971 standards, and Canadian Medical Device Regulations (CMDR).

Essential Functions

Maintains and updates the QMS system to ensure compliance with current regulations and standards and approval according to ISO 9001 and ISO 13485. Management of customer facing quality processes to provide timely and professional reply to customer complaints, requests for information, host of audits, quality agreements etc. Acts as the focal point for ISO, Regulatory and Customer Audits of the Quality Management System. Management of internal audit program and identification of nonconformance observations and opportunities for improvement in the quality system. Management of supplier quality processes as audits and agreements. Oversees the corrective actions and preventive actions (CAPA) process and monitors its performance. Manages Change Management process and monitors its performance. Monitors all reports of non-compliance resulting from customer, registrar and regulatory audits to ensure corrective action plans are in place Manages to ensure site procedures are in alignment with divisional and corporate quality guidance documents. Provides leadership in steering all quality management systems activities as Management Review process, Training, Change Management Process, Corrective/Preventive Action system and Internal Audit program. And manages to ensure all associated boards are conducted per defined time interval. Ensures Management is informed in a timely manner of changes / trends in the Quality Management System regulations and standards. Performs other duties as needed.

Skills and Abilities

  • Well organized and structured.

  • Ability to effectively lead, manage, train and motivate a diverse group of employees.

  • Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.

  • Ability to use some or all of the following PC applications: Word, Excel, PowerPoint

Qualifications

  • Minimum 3 years’ experience in Quality Systems Management.

  • Working experience with ISO 13485 and compliance with Medical Devices (MDD 93/42/EEC, FDA 21 CFR Part 820).

  • Bachelor’s degree in related field, or consideration of an equivalent combination of education and experience.

  • ISO 13485:2016 Lead Auditor Certification preferred.

  • Previous supervisory experience required.

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!

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.

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. 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 your career.

This position has been approved for relocation.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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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