Engineer II, Quality

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description As part of the Thermo Fisher Scientific team in Fremont, California, 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. At Thermo Fisher Scientific's 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 Bachelor's 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 The salary range estimated for this position based in California is $72,000.00-$96,000.00. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.