Quality Specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific Inc., we offer an outstanding opportunity for a Quality Specialist to join our ambitious team. As the world leader in serving science, we strive to enable our customers to make the world healthier, cleaner, and safer. If you are looking for a role where you can contribute to flawless operations and world-class standards, this is the place for you.

The role is accountable for ensuring TFD quality systems are effective and aligned with ISO 9001 and ISO 13485 compliant standards, meeting local and international regulations. Compliance risks must be strictly understood and mitigated to avoid impact to the business.

Key Responsibilities:

• Support the successful configuration, implementation, maintenance, and improvement of technology for 550+ staff across 20+ offices in 17+ countries;

• Assist colleagues in User Management, crafting and disabling accounts, assigning roles, and handling leave of absence;

• Manage Training solutions, curriculum, and document collaboration to support Regional Quality Management;

• Build/modify/archive courses, exams, and manage classes;

• Troubleshoot issues, manage mailing box, and coordinate Service Now tickets;

• Follow-up on metrics, participate in risk assessments for NC/CAPA, and build necessary reports;

• Work closely with the TFD Supplier Quality Team and Quality Management Representative team to understand priorities and build solutions for business partners;

• Collaborate with relevant partners to ensure efficient processes and participate in projects for improvements, new sites, and new divisions;

• Assist the Quality Management Systems Lead in other Quality Assurance activities as directed;

• Support local employees in Quality activities.

Requirements:

Education:

• Graduate or equivalent in Microbiology, Biomedical Science, or Biological Science.

Experience:

• MasterControl administration expertise (3+ years);

• Experience with ISO 9001, ISO 13485.

Knowledge, Skills, Abilities:

• Knowledge of IVDs and Medical devices;

• Excellent oral and written communication skills;

• Capability of working independently and with self-sufficiency;

• Ability to work in a matrix organization;

• Presentation skills and the ability to influence across various functions;

• Professional command of English;

• Integrity, Intensity, Innovation, Involvement.

We offer:

• The innovative environment of the rapidly growing international company;

• Energetic, diverse and highly motivated team;

• Hard-working, driven and supportive working culture and outstanding development possibilities to increase your potential;

• Competitive salary, plus annual incentive bonus, healthcare, Multisport Card, pension plan, a company stocks program and a range of employee benefits;

• Excellent career progression opportunities with a large and growing global employer.

At Thermo Fisher Scientific, each one of our 120,000 extraordinary minds has a unique story to tell. Join us and

contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.