Engineer II, Quality

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team in Fremont California youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

At Thermo Fisher Scientifics Fremont facility we work together to accelerate research solve complex analytical challenges improve patient diagnostics drive innovation and increase laboratory productivity. We know that our people are the source of our global success and we embrace the unique qualities and differences of each of our professionals. The diverse skills and abilities of our colleagues across the Specialty Diagnostics Group (SDG) drive innovation create cutting-edge solutions and deliver proven results to help our customers achieve their goals faster.

The Clinical Diagnostics Division (CDD) in Fremont California is dedicated to developing innovative diagnostic solutions that help healthcare professionals make more accurate and timely treatment decisions. Our team in Fremont plays a crucial role in advancing our mission to enable our customers to make the world healthier cleaner and safer.

Description:

As a Quality Engineer II supporting IVDR registrations at our Fremont CA site responsibilities include a mixture of 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. This position will also evaluate stability data and generate stability reports to support IVDR and product registrations.

Key Responsibilities:

• Responsible for quality release of raw materials and finished good products at the Fremont facility
• 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 bring up significant quality issues hindering lot disposition as a liaison to quality management
• Serve as a liaison with manufacturing to coordinate product release activities to best support production build and shipping schedules in Fremont
• Collaborate timely with multi-functional teams to aid effective investigations & problems 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

Requirements:

Minimum Qualification/Requirements

• Bachelors degree in life science engineering or other related science or 3-5 years relevant experience
• Hands-on experience in medical device manufacturing in quality assurance/control operations with strong working knowledge of FDA QSR IVDD/IVDR and ISO 13485 is preferred
• Familiarity with the biotech and medical device industry in the San Francisco Bay Area is a plus

Expertise: Knowledge & Skills

• Knowledge of quality policies internal procedures FDA ISO and/or IVDR regulations for manufacturing operations
• Knowledge of TFS manufacturing processes and documentation particularly those used in the Fremont facility
• Knowledge of Product Release processing and associated requirements
• Strict attention to detail 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 spreadsheet 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 competing priorities effectively
• Technical aptitude (i.e. able to read and comprehend technical documentation & execute procedures)
• Demonstrate support to a positive quality culture

Compensation and Benefits

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: Experience:

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