POSITION TITLE: Designee Quality Specialist- India

REPORTS TO: Global RA Manager

LOCATION: Noida, India

PURPOSE OF THE ROLE

Designee Quality Specialist is responsible for ensuring compliance of medical devices with applicable regulatory requirements, quality standards, and internal quality management system procedures. The role supports product development, manufacturing, risk management, validation activities, and regulatory inspections while acting as a designated quality representative for assigned projects and product lines.

KEY RESPONSIBILITIES

1. Design Quality and Product Development

- Serve as Quality representative on cross-functional product development teams.
- Review and approve Design Control documentation including: Design Plans, User Needs, Design Inputs, Design Outputs, Design Verification and Validation, Design Transfer Documentation
- Ensure compliance with Design Control requirements and risk management activities.

2. Usability Engineering

- Ensure compliance with usability engineering requirements under International Electrotechnical Commission IEC 62366-1 and applicable regulatory requirements.
- Develop and maintain the Usability Engineering Plan, Identify intended users, use environments, and user interface characteristics.
- Conduct use-related risk analysis and identify potential use errors and hazardous situations.
- Define user needs, intended use, and primary operating functions.
- Support development of user interface specifications and usability requirements.
- Coordinate formative usability evaluations during product development.
- Review labelling, Instructions for Use (IFU)



& ensure usability considerations are integrated with Risk Management activities under ISO 14971.

3. Others

- Identify gaps in Design History Files (DHFs), Technical Documentation, Design Control records, and Quality Management System documentation, and develop remediation plans to achieve compliance with applicable regulatory requirements.
- Conduct design quality gap assessments against FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, MDSAP, and internal quality procedures.
- Defining and documenting product testing requirements based on intended use, regulatory requirements, applicable standards, risk management outputs, and design changes.
- Coordinate internal and external testing activities with accredited laboratories and ensure testing is completed in accordance with recognized standards.
- Evaluate test results, identify non-conformities, perform root cause analysis, and recommend corrective actions where required.

MINIMUM REQUIREMENTS / QUALIFICATIONS

Education & Experience:

- Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline (or equivalent experience)
- Minimum 2–5 years of experience in quality engineering experience in the medical device, pharmaceutical, or regulated healthcare industry.
- Experience supporting manufacturing quality and validation processes.
- Working knowledge of ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), and MDSAP requirements.

EEO STATEMENT

We are an Equal Employment Prospect Employer and do not discriminate against applicants based on race, age, religion, sex, sexual orientation, gender identity, disability, or any other protected characteristic.

Pay: ₹6,000,000.00 - ₹12,000,000.00 per year

Work Location: In person

📌 Design Quality Specialist (India)
🏢 Gentell
📍 India