QA Manager - Medical Device

Role & responsibilities

1. Continuous improvement of QMS and initiating, creating, and maintaining QMS documents.
2. Working in coordination with the holding company with the QA-RA team of the company in holding company in Australia.
3. Adopting changes on SOP, Forms, and QMS based on design and development work undertaken by the holding company in Australia.
4. Independently support and participate in External audits and participate/conduct internal and supplier audits.
5. Implementation and review of all the Quality Standards required in the Medical Device Industry along with Risk Management.
6. Perform audits for the products /suppliers according to applicable standards or regulatory requirements (e.g., ISO 13485, MDSAP, EU MDR etc.)
7. Maintain the necessary audit qualifications and work to upgrade them as well as any other pertinent certifications as necessary.
8. Provide timely and accurate reviews of corrections, corrective/preventive actions, and closure. Provide inputs and training on department/division procedures, policies, and outside QA.
9. Provide timely status updates to management by communicating findings, engagement risks, and potential issues.
10. Develop templates and training based on the quality system regulations, applicable standards, and guidance.

Key Technical Competencies

1. Strong working knowledge of standards, auditing experience, regulatory requirements, standards, and quality management systems for medical devices:

2. Exposure to US FDA (21CFR parts 820), European MDR, ISO 13485, ISO 14971, MDSAP Audit methodology

3. The company being an exporter to 70 countries you should be skilled enough to read and understand the regulatory requirements of different countries.

Preferred candidate profile

• Preference will be given to candidates having experience in BSI, SGS, TUV, DNV