Consultant - Quality Management System - Manufacturing

Key Responsibilities include :

- Lead Audit Planning, Scheduling and conduct internal audits

- Lead opening meeting, Closure meetings, audit results formalization and closer

- Lead Corporate audit and all external audits are complete

- Guide the team in development of QMS procedures and forms based on the requirements of ISO13485, ISO14971 and 21 CFR 820 requirements

- Act as a Project coordinator to review the project deliverables to ensure compliance to the defined processes

- Management Review coordinator for the QMS. Related to Conduct of the MRM and keep up the records

- Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any non-conformities cited during audits.

- Will ensure compliance to GDP and Quality Management System requirements

- Identify areas of opportunity and support continual improvement of the Quality Management System

- Identify, develop, and report QMS metrics on a periodic basis

- Documents and Records control

- Will support vendor/ supplier management issues.

- Assist and perform Vendor/ supplier Audits

- Assist and perform Vendor/ supplier partners Training

Skill Set :

- Trained Internal/ Lead auditor on ISO9001/ISO13485 (Good to have).

- Demonstrated experience in developing quality management systems; design and development of training programs/courses;

- Demonstrated auditing experience in a manufacturing environment including the commercial set ups.

- Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have)

- Hands on experience of Conducting Management Review Meetings

- Demonstrated ability to effectively advocate a strategic quality systems approach and ensure compliance.

- Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.

- Demonstrated organizational and written/verbal communication skills.

- Demonstrated ability to self-motivate

- Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

- Demonstrated ability to prioritize tasks in a deadline-driven environment.

- Medical Devices domain experience is desirable.