• Support all QA activities for the commercial organization.
• Ensure compliance to ISO 13485:2016 & GDPMD requirements.
• Work with cross functional teams to ensure compliance and improve processes within the sales, marketing and distribution channels.
• Conduct internal audits and support external audits by certifying agencies.
• Conduct product and process quality checks following established work instructions and sampling plans, and ensure that all products and processes meet the standards, and customer, quality, and regulatory requirements.
• Maintain QMS documentation to current standards & needs.
• Handle customer complaints.
• Proactively monitor sources of trends, complaints, failures, deviations, and changes to find opportunities for system, process, and product improvements.
• Ensure effective closure of non-conformances, and corrective and preventive actions.
• Build awareness on quality system requirements within the organization.
• Conduct supplier audits and coordinate quality holds and recalls.

Requirements:

• Male or female, aged 28-35 years old.
• Bachelor’s Degree or higher in Biotech/Engineering/Pharma.
• At least 2-5 years of experience in quality assurance. Preferably in the healthcare or medical device industry.
• Experience in Implementing QMS as per ISO 13485-2016 / ISO 9001:2015/GDPMD requirements.
• Experience in conducting audits.
• Internal audit training certification for ISO 9001:2015 or ISO 13485:2016 or GDPMD requirements.
• Good command of English.