General Manager - Quality - Medical Devices & Disposables

Our client is a Japanese company working across the globe and they are one of the leading manufacturers of medical devises and other medical related products are looking for GM Quality to be working from Trivandrum Kerala.

General Manager - Quality Medical devises and medical disposables

Must : Candidate must connect with S Krishnan at 00918309618146

Must : Minimum 15 years of Bachelor's degree in Engineering or Masters in Scientific field

Must : AQL Certification, formal LEAN manufacturing training and/or Six Sigma, Quality (FTQ) initiatives;

Must : Experience in manufacturing/operations quality role leading and overseeing group of engineers and scientists

Other requirements :

- Knowledge of U.S. and international medical device regulations and standards (including CFR 820, MDD and ISO 13485).

- Knowledge on pharmaceutical solutions manufacture and testing (EP, USP and IP)

- Understand medical device and high volume disposables manufacturing

- Scientific problem-solving skills using industry accepted tools such as DMAIC, KT Analysis, or equivalent.

- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to operations

ESSENTIAL DUTIES :

- Operations Quality areas of ownership, management, and responsibility may include (as assigned): Incoming product testing, QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Nonconformance investigation and controls, Product Release, Supplier management, CAPA, Audit (internal, external, supplier), ,

- Quality System Training, Document Control, Management Review, etc.

- Oversee Quality Engineering, Calibration department, Receiving Quality Assurance (RQA) through final Quality Control and release, with other Operations Quality functions as required.

- Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.

- Identify and drive improvement projects to either gain efficiency, improve product quality or cost down.

- Oversee and manage non-conformance (NC) process and root cause investigation. Work with cross functional team to drive improvements to systemically eliminate repeat NCs or other forms of variation or defect.

- Partner with other functions or quality departments to monitor and manage quality across both design transfer or supply chain to ensure high quality production for either new product development or older products.

- Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.

- Owns and executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations to ensure efficiency and compliance. This likely includes: generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.

- Serves as Point of Contact, Subject Matter Expert and process owner for their QMS area(s) of responsibility during audits and inspections.

- Monitors the product quality and compliance health of the QMS areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.

- Identifies and implements continuous improvement opportunities within their area(s) of responsibility.