Thermo Fisher Scientific Staff Quality Engineer/Scientist in Santa Clara, California

Job Description

Job Title : Staff Quality Engineer/Scientist

Requisition ID: 69571BR

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 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, deliver medicines to market 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 services.

Responsibilities:

  • Leads/participates in cross-functional and multi-site team projects (e.g. sustaining NPI, Risk Assessments, Complaint/Product Investigations) ensuring that project deliverables and investigations comply with quality standards and regulations.

  • Responsible for ensuring that design activities are appropriately defined, executed and reported in support of effective transfers to manufacturing.

  • Guides development and implementation of validation plans and master validation plans.

  • Provides guidance in planning and execution of risk management activities and deliverables.

  • Guides resolution of complex and critical problems, including identification of root cause, and ensures corrective/preventive actions are identified to ensure timely resolution of such problems

  • Manages the Internal Audit Program and Microarray Quality Metrics

  • Manages Training and Learning Management System (LMS)

  • Manages and supports Engineering Change Control process by reviewing Engineering Change Requests

  • Prepares clearly written business communications, investigation summaries, policies and procedures

  • Supports RUO and GMP activities

  • Participates in continuous improvement.

Minimum Qualifications:

  • Bachelor’s degree, preferably in biology, chemistry, biotechnology or related science.

  • Minimum 10 years Quality Assurance or related experience with working knowledge of FDA QSR’s, ISO 13485 and/or cGMP environments.

  • Experience leading risk management

  • Experience with Design Control/Design Transfer/Design Changes and Process Validation/Analytical Method Validation

  • Must demonstrate sound independent judgment and the ability to apply quality standards and regulations to operational processes and activities

  • Must demonstrate effective leadership in guiding project teams to adopt practices consistent with ISO 13485 and GMP requirements, as applicable

  • Strong computer skills (MS Office, Visio, Project); experience with SAP, Agile, TrackWise and database systems preferred.

  • Must have effective communication skills and demonstrated ability to work collaboratively and cross-functionally

  • Must demonstrate strong organizational skills and attention to detail.

  • Must be able to acknowledge sense of urgency, adapt to organizational changes and work in a fast paced environment

Preferred Qualifications:

  • Master’s degree is a plus.

  • Working knowledge of FDA QSRs and ISO 13485

  • Experience facilitating CAPAs, reviewing/analyzing data, working on product development teams, and Training

  • Certified Quality Engineer (CQE)

  • Certified Quality Auditor (CQA)

This position does not have relocation assistance

At Thermo Fisher Scientific, each one of our 65,000 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.