Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our company’s Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Location/Division Specific InformationJoin our dynamic team in Middletown, VA where you will work within a division committed to excellence and innovation.
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.
Approve process and product validations (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
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
Direct experience working with ISO 13485:2016 and 21 CFR 820 required
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.
This position may require standing for long periods and working in a lab or manufacturing environment.
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What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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