Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Location/ Division Specific Information
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San Jose, CA / Analytical Instruments Group, Chromatography and Mass Spectrometry Division
How will you make an impact?
The Quality Specialist is responsible for leading corrective and preventive actions and customer complaints process. Quality Specialist is responsible for processing and closing all medical device/IVD, product safety complaints ensuring that all required documentation is maintained per the Complaint Handling Procedure. The Quality Specialist will perform the evaluation of customer complaints for Medical Device Report (MDR) and Vigilance reports (MDV). The Quality Specialist is also responsible for leading Corrective Action and Preventive Action (CAPA) program. This individual works directly with the cross functional CAPA owners to ensure that CAPA processes are closed optimally and on time. They also report Customer Complaints and CAPA trending activities and metrics to management.
What will you do?
- 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.
How will you get here?
- Education:
- Minimum required education: Bachelor's degree.
- Degree in Science or Engineering is preferred.
- Experience:
- 2+ years as a QA professional (in a CE/IVD or FDA supervised company preferred).
- Experience in the medical device industry, pharma and/or highly supervised industry is preferred.
- A qualified auditor of ISO 13485 Quality Management Systems is preferred.
- Familiarity with SAP or analogous ERP software systems, Trackwise, MS Word, MS PowerPoint, MS Excel is preferred.
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.
Compensation and Benefits
The salary range estimated for this position based in California is $90,900.00-$121,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards