Quality Specialist, II

Location
Fremont, CA
Salary
Competitive
Posted
September 04 2017
Ref
54367BR
Position Type
Full Time
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 Specialist is responsible for site QA support including audit readiness and audit hosting logistics, identifying and implementing improvements, collection and reporting on management metrics, preparing management presentations, analyzing and reporting data, reviewing and approving documents.

Key Responsibilities:

  • Provide additional support and assistance on tasks and projects with minimal direction from management
  • Responsible for site audit readiness
  • Provide support to internal and regulatory audits/inspections as required
  • Responsible for reviewing, improving, and approving Quality System Documents
  • Provide support to Operations in gathering and analyzing process control data using Quality Tools
  • Under general supervision, analyzes trend reports and recommends corrective action where necessary
  • Analyze situations or data, exercising sound judgment within defined procedures and practices to determine appropriate action
  • Participate on Project Teams as a contributing member and assist with internal audits as required
  • Develop and implement Quality System procedures as directed

Minimum Requirements/Qualifications:

  • BS degree in technical field or equivalent experience required.
  • Minimum 2 years of experience within the medical device. industry. Document Management experience preferred.
  • Ability to maintain confidential information to meet deadlines, manage priorities, accuracy and attention to detail is critical.
  • Demonstrate strong understanding of Quality Systems fundamentals, Electronic Document Management Systems (EDMS) (in MasterControl and Agile systems), knowledge of the process, effects, and the relationship between the document change process and products, and understanding of current Medical Device industry and applicable regulations including 21 CFR, ISO, GxP, ICH, etc.
  • Excellent written and oral communication skills, and a strong track record of working cross functionally.
  • Demonstrated ability to think strategically.
  • Demonstrated ability to manage multiple activities and tasks.
  • Must have demonstrated use of quality tools methodologies, and strong computer skills.
  • Self-starter and able to work under minimal supervision.
  • Strong ability to persuade and influence others.
  • Strong written and verbal communication skills.

This position has not been approved for Relocation Assistance.

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.




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.