Thermo Fisher Scientific seeks team members dedicated to delivering top-tier solutions for global health and safety
Requirements
- Direct experience working with ISO 13485:2016 and 21 CFR 820 required
- Experience with ISO 14971:2019 and EU Regulation 2017/746 preferrable
- Demonstrated knowledge of Quality Management Systems, continuous improvement methodologies
- Experience prioritizing conflicting demands
- Proficient with Microsoft tools (Word, Excel, Power Point, Teams) and MiniTab
- ASQ certification is desired
- Demonstrated proficiency in statistical analysis techniques is a plus
Responsibilities
- 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
Other
- 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
- Strong analytical, problem solving, and teamwork skills are required
- Excellent interpersonal, organizational, and influencing skills
- Excellent communication, written and presentation skills
