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Senior Manager - Quality - Medical Device Firm (8-15 yrs)
Only candidates from Medical Device Company needed
a. Develop and plan Quality projects and activities (e.g., Quality Assurance, Quality Systems, Supplier Quality) with accountability for successful completion of all project deliverables.
b. Provide direction and guidance to project teams to execute tactical Quality projects and/or initiatives.
c. Identify and evaluate Quality-related process improvement and/or course correction/course alignment opportunities.
d. Develop Quality goals according to strategies.
e. Ensure successful achievement of Quality objectives
a. Conduct and manage the quality activities (e.g., internal and supplier audits, FCA, CAPA/NCR, management reviews, PRA, ISO certification, Quality NPI Execution) of a small team and may indirectly manage cross-functional or matrix teams as appropriate.
b. Identify risk, develop and lead in the implementation of quality strategies which may include negotiations with internal and external parties
c. Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross-functional and/or matrix teams
d. Conduct inspection of all return products including THV at Mumbai Warehouse as per Procedure by:
e. Management of nonconforming product: define final disposition, record and evaluate information related nonconforming product
f. Support in Implementation a robust process to better control and manage Distributors
- Minimum of 10 years professional experience in Quality Management in a medical or pharmaceutical Quality environment. Experience of working with US companies/exposure to US environment. Preferably with some experience in warehouse management.
- Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
- Adequate knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, Drug & Cosmetic Actsthe relevant regulatory requirements in-country, and all other applicable requirements.
- Experience of Regulatory Inspection/ Local Inspection preferred.
- Project management skills
- Expert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
- Expert understanding of related aspects of quality processes and/or systems
- Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business
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