Sr Manager - Quality/R&D

Title : Sr. Manager – R&D

Reporting to : Director – AMEA R&D / Global QA Director

Location : Gurgoan

Job Description:

- The candidate needs to be a self-motivated leadership skills to develop and lead an R&D Quality organization and function.

- The individual will lead the development, implementation and management of the Quality systems as per IS 13485, regional regulatory requirements and company global quality systems and Product Lifecycle Process (PLCP).

- The candidate will also be responsible to lead a team of quality engineers to support all the R&D projects in the AMEA R&D.

- Ensure implementation of Design assurance and global documentation requirements.

- The candidate will be responsible to develop SOP’s and standardize the quality systems across all projects and divisions and also lead the quality certification and annual and period audits at a systems and project level.

- The individual needs to excel in people management with limited general supervision.

- Strong technical background and project management skill to manage new product development projects for medical device (Class II & III).

- The candidate will be responsible to develop the Quality systems function from scratch including regional SOP’s and will work closely with global Quality system lead to develop local quality systems and provide audit support.

- The candidate will also be responsible to lead CAPA processes, Risk management as per ISO14971 and ensure that the R&D center meets all global and regional quality measures and maintain quality function matrix for management report out.

Pramendra Singh
Synergy HRD Consultants Pvt. Ltd.