Job Responsibilities & Duties
- Plan, establish and maintain a quality management system in accordance with ENISO 13485 and MDSAP.
- Develop standardized production, quality, and customer-service standards.
- Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
- Identify and implement CAPA for non-conformance observed during any stage of the lifecycle of medical device, in internal/external audits or as a product complaint.
- Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.
- Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.
- Working closely with product development and product transfer teams.
- Releasing final product and disposition of Non-conforming material.
- Maintain product traceability and finished goods release processes.
- Support projects and new product introductions by establishing key checkpoints for new products and processes.
- Supplier audit and Qualification.
- Responsible for all clean room, and packing activity as per the QMS requirement.
- Build a strong team through coaching, mentoring, specific training and performance evaluations.
- Any other duties as assigned.
Desired Candidate Profile
- Bachelors/Master’s degree in Mechanical Engineering.
- 10+ year relevant work experience from Medical Devices & Automotive Industry.
- Must have ISO 13485:2016 internal Auditor certificate
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
- Excellent computer and internet search skills.
- Strong ability to multi-task and to meet business deadlines.
- Excellent organizational skills with an ability to think proactively and prioritize work.
Role:Quality Assurance/Quality Control Manager
Salary: 6,00,000 - 12,00,000 P.A.
Industry:Medical Devices & Equipment
Employment Type:Full Time, Permanent
UG:B.Tech/B.E. in Plastics, Automobile, Production/Industrial, Instrumentation, Biomedical, Mechanical, Metallurgy
PG:Post Graduation Not Required
Doctorate:Doctorate Not Required
Bee5 Manpower Consulting