**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking 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.
**Job Summary**
The Senior Manager, Quality leads the creation, maintenance, and ongoing refinement of the Quality Management System for the company's worldwide medical device and combination product portfolio. This role ensures adherence to global regulatory requirements (FDA 21 CFR Parts 4, 210, 211, and 820; ISO 13485; ISO 14971; EU MDR; and ICH Q10) and alignment with company quality guidelines. The individual collaborates with various departments to incorporate quality procedures throughout the product lifecycle, supporting inspection readiness and sustained global compliance.
**Key Roles and Responsibilities:**
Quality System Management
+ Coordinate implementation and governance of the global QMS for medical devices and combination products.
+ Ensure consistency with corporate pharmaceutical quality systems while adhering to device-specific requirements.
+ Own key QMS elements such as CAPA, Change Control, Management Review, Risk Management, Supplier Quality, and Internal Audits.
**Regulatory Compliance & Audit Readiness**
+ Maintain compliance with global regulatory requirements and ensure continuous inspection readiness.
+ Lead responses to regulatory inspections, internal audits, and health authority inquiries.
+ Monitor and interpret emerging regulations and standards, ensuring proactive updates to the QMS.
**Cross-Functional Leadership**
+ Collaborate with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to embed quality principles throughout development and commercialization.
+ Provide expert mentorship on device and combination product regulations and quality system integration.
+ Develop and mentor team members, encouraging a culture of quality excellence and accountability.
**Continuous Improvement**
+ Leverage metrics and risk-based analysis to drive QMS improvements and operational efficiency.
+ Implement global harmonization initiatives and digital transformation (e.g., eQMS systems).
+ Promote guidelines across sites and functions through training and knowledge sharing.
**Education**
+ Bachelor's or advanced degree in Engineering, Life Sciences, or related field.
**Experience**
+ 10+ years in Quality Assurance within the pharmaceutical and/or medical device industry, including combination product experience.
+ ASQ or Lead Auditor certifications preferred.
**Knowledge, Skills, Abilities**
+ Deep knowledge of global regulatory frameworks (FDA, ISO, EU MDR, ICH).
+ Proven experience leading global QMS programs and supporting regulatory inspections.
+ Strong leadership, collaboration, and communication skills across matrixed global organizations.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!
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.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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.