Job Description

Responsibilities:

• To formulate, implement and review work procedures to ensure effectiveness and efficiency to meet quality and regulatory requirements.
• To ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirements in all assigned areas.
• To support the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.
• To ensure overall compliance adequacy and operational effectiveness of the QA Operations (QA incoming, in-process QA and DHR management) for the contact lens and lens care products manufacturing.
• To work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield. Leading and participating in quality improvement programs and cross functional projects.
• To conduct / coordinate failure analysis for customer complaint returns. To manage customers’ complaint by coordinating with internal and external departments and submission of QA CAR to customers.
• To coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.
• To ensure that the Quality and company objectives set by Managing Director and/or Chairman are achieved, and that the business activities have the correct organization and people to achieve maximum performance in the short and continuing long term.
• To develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, CE Certification, MOH Certification and other GMP systems.
• To promote awareness, implement and enforce the company’s QMS and regulatory requirements for the improvement of current processes, controls and quality systems.
• To review, update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides.
• To ensure that gap analysis is performed on deficiencies caused by the updating of versions/editions of Standards, Guidance and Technical Guides.
• To act as QMR and PRRC with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.
  

• Degree in Engineering, Life Sciences or equivalent.
• ISO 13485:2016 lead auditor
• At least 3 years quality management related experience in medical device industry with minimum 2 years experience in regulatory affairs.
• Familiar with cGMP and EU MDR 2017/745 requirements.
• Trained auditor in ISO 13485:2016 system.
• Experience in the Application of Risk Management (ISO 14971:2019), FMEA and Application of Usability Engineering (EN 62366-1:2015).
• Understanding of ISO 13485:2016, EU MDR 2017/745, US FDA QSR, MDSAP and MY-MDA requirements.
• Understanding of quality control/assurance methodology and Sampling Plan by Attributes and its applications.
• Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.
• Knowledgeable in Validation/Qualification process.
• Able to adapt in a fast-paced environment with minimum guidance.
• Possess strong leadership, positive attitude and good interpersonal skills.
• Fluent in written and spoken English.
• Proficient in Minitab and MS Office applications.
• Strong technical writing skills.
• Team player with good and positive working attitude.
• Effective in decision making capabilities.
• Good eyesight
• Meticulous in preparing reports, protocols and other documentation.