Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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 Information

Join 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

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

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.