Responsible to ensure that products released at the different production stages meet all predetermined requirements, and production activities are performed in regulatory compliance per FDA 21 CFR part 820 and ISO 13485:2016. Contributes and participates in the activities required to achieve the quality performance metrics and guarantee the continuous effectiveness of the QMS.

• Lead, participate and contribute to achieve the quality performance metrics.
• Follow up with owners of CAPAs, NMRs, Customer Complaints to ensure these are addressed on a timely manner.
• Ensure production activities meet the Regulatory Compliance with FDA 21 CFR part 820, ISO-13485:2016.
• Provide support to other departments to develop and implement cost saving projects, scrap reduction projects and quality improvement projects.
• Perform Internal Audits and provide support on external audits.
• Develops, modifies and maintains updated t...