Thermo Fisher Scientific is hiring for a Quality Specialist II position in Bangalore, India. This is a full-time, fully onsite opportunity for professionals with a background in Life Sciences, Biomedical Sciences, Pharmacy, medical devices, IVD, regulatory affairs, or quality.
The role is part of a centralized Post-Market Surveillance (PMS) Center of Excellence (CoE) and focuses on maintaining and updating approved PMS documentation, including PMS Reports, Periodic Safety Update Reports (PSUR), Post-Market Performance Follow-up (PMPF) documentation, and literature reviews.
According to the job description, candidates should have a bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmacy, or a related discipline and approximately 1–3 years of experience in medical devices, IVD, regulatory, or quality environments.
Thermo Fisher Scientific operates a broad India presence supporting life-sciences research, diagnostics, clinical development, data management, and other scientific functions.
Thermo Fisher Scientific Quality Specialist II – Job Highlights
| Particulars | Details |
|---|---|
| Company | Thermo Fisher Scientific |
| Job Title | Quality Specialist II |
| Job Requisition ID | R-01355653 |
| Location | Bangalore, India |
| Work Mode | Fully Onsite |
| Employment Type | Full Time |
| Work Schedule | Monday–Friday |
| Experience | 1–3 years |
| Qualification | Bachelor’s degree |
| Relevant Fields | Life Sciences, Biomedical Sciences, Pharmacy or related |
| Primary Area | Post-Market Surveillance / Quality |
| Industry | Medical Devices / IVD / Life Sciences |
About the Quality Specialist II Role
The Quality Specialist II will support global Business Unit Post-Market Surveillance teams through a centralized Center of Excellence model.
The position primarily involves updating previously approved PMS documentation using analyzed data supplied by Business Unit teams. The specialist will work with standardized templates and processes to maintain consistency, traceability, accuracy, and audit readiness.
The role is particularly relevant for professionals interested in medical device post-market surveillance, PMS documentation, quality assurance, regulatory compliance, and IVDR/MDR-related activities.
The position does not carry final legal responsibility for PMS report approval. That responsibility remains with the respective Business Unit PMS teams.
Quality Specialist II Responsibilities
Selected candidates will be responsible for:
- Updating approved PMS reports using data provided by Business Unit PMS teams.
- Maintaining and updating PMSR, PSUR, PMPF, and literature review documentation.
- Ensuring annual or periodic PMS documentation updates are completed on time.
- Maintaining document version control and traceability.
- Compiling and integrating Business Unit data into standardized templates.
- Reviewing documents for clarity, accuracy, consistency, and audit readiness.
- Identifying inconsistencies or potential safety signals and escalating them to appropriate Business Unit teams.
- Collaborating with global PMS teams to collect required inputs.
- Incorporating feedback received from Business Unit stakeholders.
- Delivering draft PMS reports to Business Units for review and approval.
- Applying standardized PMS templates and processes.
- Supporting continuous process improvement within the PMS Center of Excellence.
What Is In Scope for This Role?
The Quality Specialist II position primarily covers:
- PMS report maintenance
- PMS documentation updates
- PMS document lifecycle management
- Centralized PMS processes
- Data integration into standardized documentation
- Version control
- Document traceability
- Audit-ready documentation
What Is Not in Scope?
The job description specifically excludes:
- Final approval of PMS reports
- Quality event investigation and tracking
- Regulatory submissions such as EUDAMED submissions
This distinction is important for candidates because the role is strongly focused on PMS documentation and lifecycle support rather than end-to-end regulatory submission ownership.
Quality Specialist II Qualification
Candidates should have a Bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmacy, or a related field.
Relevant academic backgrounds can therefore include:
- B.Pharm
- B.Sc. Life Sciences
- B.Sc. Biomedical Sciences
- Bachelor’s degree in related biological sciences
- Other relevant Life Sciences qualifications
Candidates with backgrounds in Pharmacy and Life Sciences may find this position particularly relevant if they also have experience in quality, regulatory affairs, medical devices, IVD, or post-market surveillance.
Experience Required
The stated experience requirement is 1–3 years in one or more of the following areas:
- Medical devices
- In-vitro diagnostics (IVD)
- Regulatory affairs
- Quality
- Related regulated healthcare environments
Experience specifically involving PMS, medical device regulatory documentation, MDR, IVDR, PSUR, PMSR, PMPF, or literature surveillance can be advantageous.
Key Skills Required
Thermo Fisher Scientific is looking for candidates with:
- Strong technical writing skills
- Data interpretation ability
- Analytical skills
- High attention to detail
- Strong documentation skills
- Knowledge of Microsoft Office
- Ability to work with standardized templates
- Good stakeholder collaboration skills
- Understanding of regulated quality environments
Familiarity with EU MDR and IVDR requirements is preferred.
Why This Role Can Be Valuable for Life Sciences Professionals
This opportunity can be relevant for professionals looking to build careers at the intersection of Life Sciences, Quality, Regulatory Affairs, and Medical Device Post-Market Surveillance.
The role provides exposure to global Business Unit teams and standardized PMS processes. It can therefore be particularly relevant for professionals who want to develop experience in areas such as:
Medical Device PMS → Regulatory Documentation → Quality Systems → MDR/IVDR → Global Stakeholder Management
Thermo Fisher Scientific describes Quality & Regulatory as a major career area focused on quality and regulatory adherence across its global operations.
Estimated Salary
The job description does not disclose an official salary range.
For editorial guidance only, a reasonable market estimate for a Quality Specialist II-level role requiring 1–3 years of relevant experience in Bangalore could be approximately ₹5 lakh to ₹9 lakh per annum, depending on experience, specialization, and the candidate’s existing compensation.
Important: This is an estimated market range and not a salary figure published by Thermo Fisher Scientific.
Work Location and Schedule
The position is based in:
Bangalore, India
The job is listed as fully onsite, with a standard Monday–Friday work schedule in an office environment.
Thermo Fisher Scientific’s India operations include locations across Bengaluru and other major Indian cities, supporting a wide range of scientific, research, clinical, manufacturing, and commercial activities.
Who Should Apply?
This Thermo Fisher Scientific Quality Specialist II opening may be suitable for professionals who have:
- A bachelor’s degree in Pharmacy or Life Sciences
- 1–3 years of relevant industry experience
- Medical device or IVD experience
- Regulatory or quality experience
- PMS documentation experience
- Technical writing experience
- Knowledge of MDR/IVDR
- Strong attention to documentation accuracy
- An interest in post-market surveillance
B.Pharm graduates with relevant regulatory, quality, medical-device, or PMS experience should consider this opportunity.
How to Apply
