Design Quality Assurance Manager

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

Life Science Solutions Group (LSG), a division of Thermo Fisher Scientific, we deliver industry-leading solutions to advance scientific discovery, enable customers in applied markets and improve global health outcomes.

This position will be based on-site at one of the folllowing locations :

Carlsbad, CA; Frederick, MD; Austin, TX; Eugene, OR; Rockford, IL; Milwaukee, WI; Grand Island, NY

Discover Impactful Work :

The will lead all aspects of the end to end’ design control and new product development lifecycle and lead a Design Quality Team.

A day in the Life :

• Lead and support Design Control activities, providing guidance to Project Core Teams on User and Product requirements, Functional Specifications, Design Verification and Validation, Risk Management, Design Reviews, Design Changes, and Design Transfer.
• Ensure activities are conducted in compliance with all applicable regulatory requirements, international standards, and internal procedures.
• Actively identify and lead initiatives toward continuous development, training, mentoring and / or coaching of staff in the Design Quality organization.
• Additional responsibilities as assigned.

Education

• BS degree in Engineering or in a Science field such as Chemistry, Microbiology, Biology, or Biochemistry.
• 7+ years of Quality Assurance experience (Quality Engineering, Quality Assurance, Quality Control, Supplier Quality).
• 5 + years of experience in New Product Introduction activities.
• 5 + years in the Medical Device, In-Vitro Diagnostics, or other regulated industry.

Experience

• Demonstrated understanding of product development lifecycles, design change and change control, product validation methodologies, design transfer, and manufacturing / production process control methodologies.
• Experience with applicable FDA, European and other relevant clinical / regulatory requirements, and international standards, including ISO 9001, ISO 13485, ISO 14971, EU IVDR / MDR, 21CFR 820 Quality System Regulation, etc.
• Mentoring and team management.

Knowledge, Skills, Abilities

• Strong verbal and written communication skills and can communicate at multiple levels in the organization.
• Ability to work efficiently within a team in a fast-paced changing environment.
• Strong leadership, including the ability to provide positive and constructive feedback to build positive relationships and improve business results.
• Experience working in a broader enterprise / cross division business unit model preferred.

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 a positive company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Oregon is $ - $

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 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) retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
30+ days ago