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Job ID :
55526BR
Location :
US - California - South San Francisco
:
Job Description

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.

The Quality System Specialist role will work within the quality management system to develop and ensure compliance with various quality standards and regulations, specifically this role will take ownership of the CAPA, Deviation, and NCR systems. In addition, this role will have a key impact on developing and implementing updates to the quality management system.

Responsibilities:

  • Apply quality systems knowledge to identify, open, manage, and effectively close; non-conformance reports, deviations, and corrective and preventive actions
  • Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports
  • Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory)
  • Monitor customer feedback to manage complaint process, including assisting in the determination of reportability to regulatory authorities
  • Monitor and maintain Quality Management System to ensure compliance with ISO 13485:2016, 21 CFR 820, and other applicable standards/regulations. This will include authoring and updating of established quality procedures and policies as well as implementation of new requirements
  • Additional support of the Quality System, including participation in quality audits, interacting with other departments to support quality goals, and other QA department functions, as needed

Essential Functions:
  • Support the quality management system by taking ownership of key quality processes
  • Apply knowledge of quality systems to develop and implement current and future quality system requirements

Contacts and Relations:
  • Regular contact and interaction with all levels of the organization
  • Daily interaction will occur with technical product owners and manufacturing personnel

Accountability:
  • All QA personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
  • Maintain a cooperative and professional relationship with other laboratory staff and departments

Minimum Qualifications:
  • Bachelor’s degree in Life Sciences or related studies
  • Four (4) years of quality experience in an IVD industry or in a cGMP, ISO regulated Medical Device manufacturing environment
  • Strong knowledge of cGMP and ISO 13485 quality system requirements
  • Familiar with ISO 14971 and its application in quality processes
  • Exercise independent discretion and judgment in execution of duties
  • Plan and organize oneself in a consistent manner
  • Be a self-starter with the ability to positively motivate others in a cooperative fashion
  • Establish and maintain effective working relationships with other staff members
  • Effectively communicate both orally and in writing to staff, management, customers and regulatory personnel
  • Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry

Ability to:
  • Provide accurate QS tracking and trending reports
  • Author detailed procedures
  • Exercise independent discretion and judgment in execution of duties
  • Plan and organize oneself in a consistent manner
  • Be a self-starter with the ability to positively motivate others in a cooperative fashion
  • Establish and maintain effective working relationships with other staff members
  • Effectively communicate both orally and in writing to management, customers and regulatory personnel
  • Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry

Preferred Qualifications:
  • Background in diagnostics
  • IEC 62304/Software Design knowledge
  • Effective implementation of quality systems in small companies


At Thermo Fisher Scientific, each one of our 50,000 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.com

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.


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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