
Senior Medical Device Quality Assurance Professional
1 day ago
The Medical Device Quality Assurance Specialist role is a pivotal position within our organization, responsible for ensuring the highest standards of quality in medical device development and manufacturing. This position requires a unique blend of technical expertise, regulatory knowledge, and analytical skills.
Key Responsibilities:- Quality Management System (QMS): Implement and maintain a robust QMS that adheres to global medical device regulations and standards.
- Regulatory Compliance: Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
- Documentation Management: Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
- Design Control & Development Support: Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Risk Management: Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Post-Market Surveillance & Vigilance: Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Supplier Management: Support the management of supplier quality and compliance.
- Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
- Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
- Communication Skills: Coordinate with internal departments and external stakeholders.
- Bachelor's Degree: Relevant field such as engineering, life sciences, or a related technical discipline.
- Experience: Previous experience in QA/RA within the medical device industry is an advantage.
Estimated annual minimum salary: 500000 INR
Estimated annual maximum salary: 800000 INR
Currency: INR
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