In general, this position is responsible to focus on Documentation Management, Quality Management System Compliance and providing quality support as Quality business partner.

This position is also responsible for providing product labels for India business in compliance with Legal Metrology and NPPA guidelines for all import shipments.

This position is responsible for supporting sustainable quality operations at the Distribution Centers which complies with the requirements of the relevant standards, corporate and local regulatory requirements.

JOB FUNCTION

Ensure timely availability of India sub labels at all the MIDC facilities

Ensure label work instructions are in place and updated. Also new Label work instruction are in place for new product launch.

Able to address day to day Quality issues

Support labeling of tender business in line with Quality requirements and local regulatory requirements.

Responsible for collecting, trending, analyzing and disseminating distribution centers metrics.

Initiate, track, follow-up and close Non-conformance, Corrective and Preventive Actions.

Responsible for review and documenting updates when necessary the quality documents in accordance with quality related regulations, etc.

Manage Excel database for all the records and tracker as per requirement of Quality related processes.

Responsible for successfully managing Internal, Notified Body, Supplier and Customer Audits in the DCs.

Executes any other tasks and/or projects as assigned by immediate supervisor.

Maintain and develop relationships with key stake holders as well as external customers.

Must have understanding of quality system and processes like Non-conformance, CAPA, RCA, 5 Why etc.

Support Quality Procedures and Policies as outlined in the Company's Quality Manual. Including support for internal QA and corporate audits of the system.

POSITION REQUIREMENTS

1. Minimum 2-3 years relevant quality assurance/regulatory compliance experience in the medical device/healthcare industry.
2. Relevant experience in quality systems for distribution and quality management, supply chain/warehouse, failure investigation, corrective & preventive action, and document & quality records management.
3. Manufacturing experience preferred in medical device.
4. Experience in interaction with FDA officials will be an advantage
5. Experience in working with cross functional team

Job Competency Requirements:

1. Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to ISO 13485.
2. Problem Solver, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions. he/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability. Must be comfortable and able to operate within a matrix organization that thrives on teamwork and consensus building.
3. Excellent communication skills.
4. Able to use Microsoft Excel spreadsheet with knowledge of formulas.
5. Able to use PowerPoint skills for creation/maintenance of organization charts and presentations.
6. Must be able to identify and resolve problems and requests in a proactive and timely manner.
7. Must be able to gather and analyze information skillfully using problem solving/root cause analysis skills.
8. Ability to exchange information clearly and concisely.
9. Ability to work in a large, fast-paced, matrixes organization with speed and accuracy.
10. Ability to work well in a team-oriented environment.

experience