Thermo Fisher Scientific is looking to solve the problem of ensuring the highest level of quality standards for their products, particularly in the Chemical Analysis Division (CAD), by hiring a Quality Engineer to collaborate with the Operations team and analyze non-conformance data, lead corrective action initiatives, and support software verifications.
Requirements
- Experience with software validation, problem solving, and issue management systems (e.g. JIRA)
- Knowledge and experience implementing the ISO 9001:2015 standard
- Knowledge and experience implementing the ISO 17025:2017 standard
- Ability to implement new programs and processes with minimal direction
- Experience using quality tools such as 5 Whys, Ishikawa Diagrams, GEMBA walks, etc.
- Proficient in Microsoft Excel
- Ability to write clear and cohesive work instructions
Responsibilities
- Develop and complete software verification and validation test plans
- Guide process improvement teams both internal and external to the company
- Provide technical support to our procurement team for second source and cost reduction activities
- Work effectively with suppliers, purchasing, production, engineering, and customer service as needed
- Hands-on software quality work, particularly in the area of establishing root cause analysis, corrective action, software validation, and SOP creation
- Analyze non-conformance data
- Lead corrective action initiatives
Other
- Bachelor of Science (BS) or Master of Science (MS) from accredited College, University, or equivalent
- Minimum of 7 years of experience
- American Society of Quality (ASQ) Certified Quality Engineer (CQE) or equivalent preferred
- Ability to lift/push/pull up to 40 pounds on regular basis
- Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time
