Manager – Quality Management Representative (QMR - ISO 13485)

Manager - Quality Management Representative (QMR - ISO 13485)
Our client is the manufacturer and global supplier of a wide range of healthcare products in Singapore. The company aims at providing innovative, sustainable, high-quality products and services to its customers.
Responsibilities:

• To ensure all in-coming materials, manufacturing processes, instruments, test methods and finished products are in complying with specified regulatory standards and requirements.
• To conduct/ support investigations related to non-conformance, non-compliance, out-of-specification, and customer complaints.
• To support, lead and improve the Customer/ Supplier Quality Management Program.
• To constantly update the current regulatory requirements/ guidelines (national & international), perform gap analysis and provide updates/ review if required.
• To establish/ adopt effective quality management systems, documentations, policies, and procedures in ensuring optimum quality assurance of all manufactured products.
• To be the subject matter expert for all regulatory certifications/ audits.
• To drive workplace safety and regulatory compliance.
• To make use of existing resource capabilities in achieving long term business objectives and goals.
• To provide and promote quality related knowledge and awareness across different functions.

• Minimally a bachelor's degree in Life Sciences or engineering equivalent.
• Minimally 3 years of quality/ regulatory affair related working experience in the Medical Devices/ pharmaceutical products manufacturing industries.
• Excellent knowledge of GMP, EN 62366-1:2015, ISO 1471:2019, ISO 13485:2016, EU MDR 2017/745, MY-MDA, US FDA QSR and other Medical Devices related regulatory requirements/ Audits.
• Proficient in using Minitab and Microsoft Suite applications.
• Excellent communication, interpersonal and leadership skills.
• Excellent documentation and technical writing skills.
• Good knowledge of process validation/ qualification, sampling plan, Risk management, FMEA, and application of Usability Engineering.
• Experienced using calipers, micrometers and lensometer.