Thermo Fisher Scientific - Franklin, MA
posted 5 months ago
About the position
At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking, and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. The Quality Engineer III will be located onsite in Franklin, MA, supporting our Chemical Analysis Division (CAD). This role is crucial in leading change as quality leaders, always improving the culture of compliance with the customer in mind. Our dedication to Quality is at the heart of our brand and vital to our growth and success. In this position, you will engage in hands-on implementation in Quality Assurance/Control, conducting audits (internal, external, and supplier), and owning CAPA processes while mentoring all business partners. You will provide support in the creation and monitoring of Nonconformances, complete Complaint Investigations, and analyze trends. Additionally, you will participate on New Product Introduction teams to provide feedback relating to product quality and compliance, as well as the quality management system. Utilizing Thermo Fisher Scientific's PPI Business System, you will drive efficiency and continuous improvement across the Quality function and continuously participate in supplier qualification and monitor supplier quality.
Responsibilities
- Hands-on implementation in Quality Assurance/Control
- Conducting internal, external, and supplier audits
- Owning CAPA processes and mentoring business partners
- Supporting the creation and monitoring of Nonconformances
- Completing Complaint Investigations and trending
- Participating on New Product Introduction teams to provide feedback on product quality and compliance
- Using Thermo Fisher Scientific's PPI Business System to drive efficiency and continuous improvement
- Participating in supplier qualification and monitoring supplier quality
Requirements
- B.S. in engineering; advanced degree a plus
- 5+ years of demonstrated ability in Quality Engineering
- Experience working with multiple projects and focus areas
- Knowledge of Six Sigma or Lean Training and/or Certification preferred
- Experience with ISO 9001-2015, 13485, and ISO 14971 preferred
- ASQ Quality Engineer certification preferred
- Proactive problem-solver with an understanding of problem-solving tools
- Excellent verbal and written communication skills
Nice-to-haves
- Six Sigma or Lean Training and/or Certification
- Experience with ISO 9001-2015, 13485, and ISO 14971
- ASQ Quality Engineer certification
