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Quality Manager GID India

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Position Summary:

Phillips-Medisize, a Molex company, is looking for a Site Quality Manager to setup a quality organization in the newly established Global Innovation and Development center in India, implement quality systems and drive key quality processes in the field of medical devices enabling us distribute world class products effectively and efficiently, thereby contributing to improve People’s lives.

With your knowledge and experience you’ll be responsible for development, improvement & implementation of quality systems as per ISO 13485. You’ll be responsible for identifying areas of improvement, driving a culture of Quality, execution of planned and systematic activities required to operate in a controlled environment, and mentoring and coaching a team.

What You Will Do in Your Role (Responsibilities):

·Plan, establish and maintain a quality management system in accordance with ISO 13485:2016.

·Lead the regional quality organization to engage with customers and regulators to deliver the highest quality experience by providing timely and professional reply to requests for information, hosting external audits (customer and regulatory agency), and reviewing quality agreements (supplier and intercompany).

·Manage the planning and post inspection response activity of External body inspections such as Notified Body Organizations and coordinating multi-site resources to ensure assessments are adequately supported.

·Lead QMS to ensure site procedures are in alignment with divisional and corporate quality guidance documents.

·Drive the internal audit program for the site, including the identification of nonconformance observations and opportunities for improvement in the quality system.

·Provide leadership in steering all quality management systems activities as Management Review, Post Market Surveillance, Training, Change Management, Corrective/Preventive Actions, Supplier, and Internal Audit processes through the applicable review boards.

·Responsible for the corrective actions and preventive actions (CAPA) process and monitors its performance. Monitor all reports of non-compliance resulting from customer and regulatory audits to ensure corrective action plans are in place.

·Represents the site in Business Unit Level Quality Management System initiatives.

The Experience You Will Bring

·Bachelor’s Degree in Engineering, Science, or technical field with work experience in Engineering and/or Quality OR Advanced degree in Engineering.

·Experience of setting up and managing a QMS in medical device design and development and/or manufacturing

·Working experience with FDA - Quality System Regulations (21 CFR Part 820), International Organization for Standardization (ISO) standards (13485:2016, ISO 9001:2015, ISO 14971:2019, and others)

·Working knowledge of the new product design, design transfer and development in a regulated environment.

·Working knowledge of the application of risk management in the medical device development domain.

·Ability to travel domestically and/or internationally 20% of time.

What Will Put You Ahead:

·Knowledge and prior experience working in SAP and Agile

·Ability to plan, direct, and maintain site-based goals and objective relating to the QMS. Proven ability to formulate Quality Operations facility strategies.

·Having represented a site in Business Unit Level Quality Management System initiatives.

·Able to proactively and independently resolve issues in creative ways as well as to lead change.

“Koch is proud to be an equal opportunity workplace” 

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