Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This role will be based in North America, preferably in Rochester, NY or Mebane, NC and lead Quality activities for our Laboratory Product Essentials (LPE) Business Unit across 8 sites globally, working with 200 quality professionals. LPE produces such products as Liquid Handling Solution products and Labware, Clinical, and Storage products. You will report directly to the Vice President of Quality and Regulatory Affairs for the Laboratory Products and Life Sciences Group.

How will you make an impact?

Our Quality culture is based on collaboration and partnership, with all of us working together to support and promote quality across the company! This position will lead the Quality function for the various LPE manufacturing sites to assure high quality products are delivered to customers, maintain a strong state of regulatory compliance and work cross-functionally to improve business outcomes.

What will you do?

• Build and drive a Quality framework and strategy for the LPE Business Unit that supports growth and compliance readiness.

• Champion quality expertise in the organization to ensure products and services are designed, developed, manufactured, and delivered right the first time.

• Provide groundbreaking leadership within the LPE organization to promote a strong quality culture ensuring customer and business expectations are continuously met and exceeded.

• Actively partner with executive sponsors to develop a value proposition grounded in quality that deepens customer relationships and facilitates business growth.

• Ensure compliance to quality system requirements (e.g. FDA CFR 820, ISO 13485/9001, IVDR) to meet requirements of regulated and non-regulated sites/products.

• Drive continuous improvement activities and projects to move the organization towards a proactive quality approach.

• Leverage key quality business metrics that align with customer expectations to drive year-over-year improvement, enabling business growth.

• Support the commercialization of New Product Introduction, technology transfer, process improvement by working with cross functional team members.

How will you get there?

Education

• B.S. Degree in STEM related field

Experience

• 10+ years of strategic Quality leadership experience in a regulated medical-device manufacturing company.

• 5+ years proven experience leading the Quality organization for multiple sites.

• Experience with external regulators.

• Experience working with and leading multiple projects and teams simultaneously across a matrixed organization.

• High volume plastics manufacturing experience is preferred

• Experience with Lean or Six Sigma improvement systems is helpful.

• 25%-30% travel requirement.

Knowledge, Skills, Abilities

• A leader who’s able to encourage and empower across the quality and operations organization

• Effectively communicates and presents to all levels internally and externally.

• ASQ Quality Manager Certified; ASQ lead auditor training is preferred.

• Training on CFRs/ISO 13485/9001 and risk management (ISO 14971) is preferred

Compensation and Benefits

The salary range estimated for this position based in New York is $145,500.00–$218,250.00.

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

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.