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Quality Specialist II

Company: Thermo Fisher Scientific Inc.
Location: Petaluma
Posted on: June 8, 2021

Job Description:

Job Description

  • Implement and maintain Quality Systems to ensure the measurement of progress towards key quality goals and objectives.
  • Maintain and develop the quality system to fulfill requirements (e.g. ISO 9001 and 13485).
  • Coordinate Management Reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/action items. Collect the information and prepare the presentation (power point) for MR meeting. Write the minute.
  • Coordinate the Petaluma internal audits to ensure compliance in a timely manner. Adherence 100% to the Calendar, planning the agenda, distribute the verification list to the auditors team, attend opening and closure meeting, write the audit report, track the Non Conformances raised in the audit (Trackwise and hard copy).
  • Support on external audits, Customers, Corporate and registration Body- BSI; track the Non Conformances raised in the audit (Trackwise and hard copy).
  • Support the team with Customer Complaints and CAPAs.
  • Support to Document Control area with activities needed in the site.
  • Participate actively in process improvement projects
  • Support with external parties on matters relating to the Quality Management System
  • Other duties as assigned.

Education

  • BA/BS in Engineering or Science or equivalent training and /or experience, with focus on Industrial Engineering and/or Quality Engineering

  • Experience

  • 3 years in Quality System area, in an ISO 9001 and/or ISO 13485 certified medical-device manufacturing company.
  • Internal Auditor of ISO 13485 and desirable for ISO9001, 21 CFR part 820
  • Strong computer skills including data-based, windows office, QMS systems: Agile, Agile eDMS, & Trackwise,
  • Experience with problem-solving techniques such as 5 Why's, 8D, DMAIC, A3
  • Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team. Must have had experience with formal goal and objectives settings.
  • Knowledge, Skills, Abilities
  • Ability to write technical reports of audit process.
  • Ability to read, analyze, and interpret common quality standards, scientific and technical journals, financial reports, and safety documents.
  • Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Language: Bilingual English and Spanish desirable.

Keywords: Thermo Fisher Scientific Inc., Petaluma , Quality Specialist II, Other , Petaluma, California

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