Quality Engineer I, Manufacturing Quality

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 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, ensuring our food is safe, or helping find cures for cancer.

Discover Impactful Work

As a quality engineer, I support IVDR registrations. My responsibilities include reviewing data, evaluating trends, generating stability protocols and reports, and releasing COAs for finished products. This position will perform routine reviews of production records to assure completion, accuracy, and compliance with cGMP. It will also evaluate stability data and generate stability reports to support IVDR and product registrations.

A Day in the Life

Responsible for the quality release of raw materials and finished good products.Timely release lots that have met all release criteria, while ensuring all discrepant lots are held until appropriate disposition.Identify timely resolution for errors in batch records and on product Certificates of Analysis.Review / Approve Certificate of Analysis when all release requirements have been verified and met.Appropriately, it brings up significant quality issues hindering lot disposition as a liaison to quality management.Serve as liaison with manufacturing to coordinate product release activities to best support production build and shipping schedules.Collaborate timely with multi-functional teams to aid effective investigations & problem-solving.Evaluate stability data and generate stability reports to support IVDR and product registrations.Review stability protocols generated by R&D or Product Support and recommend changes as needed.Continually identify, recommend, and implement process improvements with a lean and quality focus, ensuring improvements are implemented in compliance with cGMP.Perform other related duties as required by management, which can include stability testing, special projects, or organizational initiatives.

Keys to Success

Education

Bachelor’s degree in life science, engineering, or other related science required.

Experience

1-3 years relevant experience preferred.Hands-on experience in medical device manufacturing and quality assurance/control operations, as well as strong working knowledge of FDA QSR, IVDD/IVDR, and ISO 13485, is preferred.

Knowledge, Skills, And Abilities

Knowledge of quality policies, internal procedures, FDA, ISO, and/or IVDR regulations for manufacturing operations. Knowledge of TFS manufacturing processes and documentationKnowledge of Product Release processing and associated requirements.Strict attention to detail is required. Problem detection and escalation ability a must.Ability to effectively work with all functional groups and levels within the organization.Effective communication skills (written and oral) and interpersonal skills.Proficient in the use of computer software, including a wide variety of ERP modules, EXCEL spreadsheets, and Microsoft Word processing.Working knowledge of MasterControl, Oracle, and QAD (ERP system)Demonstrated collaboration, negotiation & conflict resolution skills.Ability to multi-task & handle tasks with challenging priorities effectively.Technical capability (i.e., able to read and comprehend user documentation & implement procedures).Demonstrate support for a positive quality culture.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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. We will gladly provide reasonable accommodations covered under the ADA.

Compensation And Benefits

The salary range estimated for this position based in California is $58,100.00–$87,125.00.

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 programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ 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