Quality Head - Healthcare

Discipline - Healthcare and Life Sciences

Subsector - Quality Assurance & Control

Location - Delhi NCR

About our Client - Our client is one of the largest OEM of Medical electrodes globally and is around $50mn currently. They have presence in over 20 countries and have tie-ups with MNCs. To fuel their growth they are looking at expanding their manufacturing capabilities and are looking for individuals who would drive the quality function.

Job Description - Reporting directly to the President, you will be responsible for:

- To monitor whether the Quality System has been implemented and is operating satisfactorily.

- Responsible to support the Business Unit Manager to perform management review, internal audits and providing QA guidance to the Business Unit.

- To support the business unit in the implementation of effective, efficient and compliant Quality Management Systems, BMS.

- Supervise the responsible department to take CAPA and implement timely.

- To provide an interface with Certification Bodies.

- To allocate and monitor cost expenditure in accordance with appropriate guidance.

- To identify and provide advice and guidance on world wide regulations throughout the organization and to ensure that up to date knowledge is maintained and implemented within the company

- To liaise with regulatory bodies.

- To identify and report any issues of concern to QA/RA management and appropriate functions.

- To promote the quality system and its principles throughout the organization.

- To assure third part manufacturers compliance competence.

The Successful Candidate - You will have a degree in Engineering with around 10-15 years experience in the QMS function. You will have experience in ISO9001:

- 2008, ISO13485:

- 2003 and come with an excellent understanding of the regulations across the world, preferably US FDA. You will have good communication skills and Interpersonal skills.

What's on Offer - Besides a competitive compensation structure, you will have a professional culture to work in.

The Apply Button will redirect you to Michael Page's website. Please apply there as well.