About the role

Aplyr's Quick Take

This role is about managing quality systems and ensuring compliance in a regulated environment, specifically within the medical device sector. You'll handle change control, deviations, and audits while supporting continuous improvement initiatives. It's primarily an individual contributor role focused on quality assurance.

Good fit

Ideal candidates have a background in life sciences or engineering with at least 3 years of quality assurance experience, particularly in medical devices. Strong analytical and communication skills, along with a detail-oriented mindset, will help you thrive here.

Worth noting

The role requires specific medical device experience, which may limit the applicant pool. The emphasis on compliance and quality metrics suggests a structured work environment that values precision and regulatory adherence.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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.

Discover Impactful Work:

This role focuses on ensuring quality and compliance within regulated environments while supporting continuous improvement and operational excellence across quality systems.

A Day in the Life:

You will support quality systems, manage compliance activities, participate in audits, and contribute to continuous improvement initiatives across regulated environments.

What to expect:

Manage and support quality systems including CAPA, deviations, and change control
Ensure compliance with GMP/GxP regulations and ISO standards
Conduct and support internal and external audits
Develop and maintain quality documentation such as SOPs
Analyze data and report on quality metrics
Collaborate with cross-functional teams to drive improvements

Keys to Success:

Education

Advanced degree plus 1 years of experience, or bachelor’s degree plus 3 years of experience in quality assurance/quality control.
MUST HAVE MEDICAL DEVICE EXPERIENCE

Experience

Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology, Validation or related technical field
Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
Experience with quality management systems, CAPA processes, deviation management, and change control
Proficiency in statistical analysis, data trending, and quality metrics reporting
Strong technical writing skills for authoring SOPs, change control, and other quality documentation
Experience conducting and hosting internal/external audits and regulatory inspections
Advanced problem-solving abilities and attention to detail
Excellent verbal and written communication skills
Strong interpersonal skills with ability to collaborate across functions and levels
Proficiency with quality systems software (TrackWise, KNEAT, Document Control Systems) and Microsoft Office Suite
Ability to work independently and guide cross-functional teams
Knowledge of risk assessment methodologies and continuous improvement tools
Project management experience preferred
Medical device change management experience is a plus
Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs

Competencies

Innovative

Customer centric

Self-motivated

Accountable

Effective Communication

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.