Director, Quality Assurance - Laboratory Plastics Essentials (LPE)

at  Thermo Fisher Scientific

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.

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

• 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.