Quality Systems Manager

Location
Pleasanton, CA
Salary
Competitive
Posted
September 12 2017
Ref
54375BR
Position Type
Full Time
Job Description
Job Title: Quality Systems Manager
Requisition ID: 54375BR

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


Responsibilities:
  • Manages all aspects of external/internal audit programs, including ISO registrar and customer audits, the internal audit program, and FDA inspections.
  • Ensures the effectiveness of the internal audit program and that there are sufficient trained internal auditors to comply with audit schedule requirements and quality standards for internal audit.
  • Hosts external audits (customer, registrar, corporate) for RUO and GMP operations. Assists with FDA inspections of GMP operations.
  • Chairs CAPA Review board and drives improvement to CAPA processes.
  • Responsible for generation of CAPA system metrics and analyzing metrics to identify improvement opportunities.
  • Leads/participates in cross-functional and multi-site team projects ensuring that project deliverables comply with quality standards
  • Provides quality training and guidance to the organization to ensure effective root cause analysis, development of corrective action plans, and audit preparedness.
  • Prepares clearly written business communications, investigation summaries, audit reports, etc.
  • Collaborates both vertically and horizontally in a way that commands both personal respect and mission acceptance.
  • Possesses the ability and interpersonal skills to influence all levels of the organization
  • Performs as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).


Minimum Qualifications:
  • Expert knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
  • Broad/well-rounded product and process knowledge
  • Comprehensive knowledge of advanced quality tools, (e.g.: SPC, DOE GR&R, CPK Analysis, etc.)
  • Bachelor's degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience
  • Minimum of 7+ years related experience in Medical Device or Pharmaceutical Industry


At Thermo Fisher Scientific, each one of our 55,000 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.


*IND-LSG


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.