Quality Specialist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to interact with individual/groups at all levels, good presentation/training skills.
• Ability to identify priorities and function independently.
  At Thermo Fisher Scientific, each one of our 100,000 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.
  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
  We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other employment benefits and privileges Please contact us to request accommodation.

• Initiate, update, and optimally close all product safety, medical device/IVD complaints.
• Lead all CAPA program activities including taking ownership of CAPA program and motivating changes where appropriate.
• Establish and innovate processes for implementing CAPAs and complaint handling in accordance with 21CFR§820 and ISO 13485.
• Advise manager of any potential reportable product safety incidents and work with Regulatory Affairs as appropriate.
• Work with Service organization to ensure accurate follow-up activities with the customer have taken place.
• Work with product investigators to ensure timely and effective investigation. Ensure adequate investigation has taken place for CAPAs and Root Cause Analysis is complete and appropriate for the issue
• Report CAPA and complaint trending data and metrics to management during quality reviews.
• Maintain professional demeanor with cross functional, technical and QA staff to acquire vital information to support documentation.
• Work cross functionally to initiate CAPAs from all identified sources, ensure timely completion of CAPA planning activities such as root cause analysis, containment, immediate corrections, corrective action plan and verification of efficiency plans.
• Perform other duties as required.