QA Manager, India

3 weeks ago

mumbai, India Align Technology Full time

About this opportunity

The APAC Regulatory and Quality Assurance Department has a position in India for a Quality Assurance (QA) Manager to support local & regional functions of the Department. This role will lead, establish, maintain, coordinate and support the India Regulatory Compliance in meeting Align’s Quality goals via an effective Quality Management System to ensure that business processes in India are in full compliance with local medical device regulations and Align’s internal requirements The position also monitors changes to applicable laws and legislations that could affect the organization in India and provides guidance to the site leadership team on matters relating to quality. This position is based in Align’s India office and reports directly to the Director, Regulatory Affairs and Quality Assurance, APAC, in the APAC corporate HQs located in Singapore In this role, you will… Develop and maintain India sites Quality Management System procedures to comply with local requirements and Align Global Quality Framework, Global QMS Policies and Global Standard Operating Procedures which ties to the ‘One Align’ and ‘Quality First’ principles to establish a Global Harmonized Quality standard. Develop and maintain sites CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification. Implements the quality audit program per APAC approved audit schedule, ensuring site audit readiness and conducts successful internal/ external audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks. Leads the preparation and coordination with site personnel to ensure the success of site audits by External Regulatory bodies as well as Corporate/APAC internal audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks. Assume the MR role for India sites, as applicable. Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with site process owners to define improvements. Inclusive and not limiting to Refurbishment and Extended Producer Responsibilities requirements. Supports new business expansion in India, ensuring its quality compliance. Assists with all department projects as required In this role, you’ll need … Must be proficient in English, with a working knowledge of other languages in APAC. Thorough understanding of India medical device laws and regulations. In depth knowledge of Quality System regulations – GMP, GDP, ISO 13485, etc., with its relevant local implementation experience and audit skills. Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials. Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change. Bachelor Degree in Science or Engineering preferred and having experience of not less than two years in testing of medical devices to head the testing activity of a medical device. 8+ years of experience in Quality Assurance role at medical device company is required

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