Quality Engineer III

Job Opportunity At Thermo Fisher Scientific

At Thermo Fisher Scientific team, 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. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. 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. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Join our dynamic team in the United States, where you will work within a division committed to excellence and innovation in the engineering field.

Discover impactful work: Thermo Fisher Scientific seeks team members dedicated to delivering top-tier solutions for global health and safety.

What will you do?

• Facilitate risk management activities in compliance with ISO 14971:2019. Maintain risk management files up to date.
• Review and approve process and product validations (TMV/IQ/OQ/PQ)
• Ensure compliance to the Quality Management System
• Collaborate with teams from different functions to develop realistic solutions to meet customer needs and solve problems.
• Review and approve CAPA action plans. Complete CAPA effectiveness checks.
• Collaborate in the resolution of non-conformances. Make product disposition decisions.
• Participate quality improvement initiatives
• Represent the quality function in customer facing meetings
• Support internal and external audits

How will you get there?

• BS in Biomedical Engineering, Industrial Engineering, Chemistry or related field.
• At least three years of experience as a Quality Engineer or equivalent position in the medical device industry or pharmaceutical industry
• Direct experience working with ISO 13485:2016 and 21 CFR 820 required

Knowledge, Skills, Abilities

• Strong analytical, problem solving, and teamwork skills are required.
• Ability to analyze and process data and draw the appropriate conclusions.
• Demonstrated knowledge of Quality Management Systems, continuous improvement methodologies.
• Experience prioritizing conflicting demands
• Excellent interpersonal, organizational, and influencing skills
• Excellent communication, written and presentation skills. Proficient with Microsoft tools (Word, Excel, Power Point, Teams) and MiniTab.
• ASQ certification is desired.
• Experience with ISO 14971:2019 and EU Regulation 2017/746 preferrable.
• Demonstrated proficiency in statistical analysis techniques is a plus.

Physical Requirements / Work Environment

This position may require standing for long periods and working in a lab or manufacturing environment.

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 an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.