We are currently looking for a Senior Quality System Engineer for a leading player in the Medical Device Manufacturing Industry with a legacy of more than 40 years in the world. This position requires your urgent attention.
- Reporting to: Senior Quality Manager
- Based in Penang
- Attractive remuneration and benefits package
the job
- Implement and maintain internal quality system requirements aligned with external laws, regulations, standards, and guidance, including FDA, ISO, cGMP, and MDR.
- Plan, conduct, and coordinate internal audits to assess compliance. Lead audit preparation, execution, reporting, and follow-up on findings. Support external inspections as required.
- Identify areas of noncompliance or improvement through routine audit activities. Participate in global meetings and conference calls related to audit processes and performance.
- Lead the implementation of effective assurance measures, process controls, and CAPA systems. Ensure CAPAs are completed on time and in alignment with regulatory expectations.
- Manage the CAPA process, develop and distribute performance metrics, and collaborate with stakeholders to ensure accurate tracking and timely resolution.
- Provide training and guidance to cross-functional teams on quality system standards and regulatory expectations to foster a culture of compliance.
- Work with business units and functions to standardize quality system procedures, improve quality practices, and support decision-making on quality-related issues.
- (If applicable) Provide quality oversight for laboratories involved in testing and batch release of combination products and raw materials, ensuring adherence to cGMP standards.
- Support investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and lab deviations. Prepare Annual Product Reviews for designated products and maintain compliance documentation.
- Collect and analyze quality system data across departments to support management reviews and continuous improvement initiatives.
the experience
- Holds a Bachelor’s degree or higher qualification
- Over 9 years of hands-on experience in a manufacturing setting, ideally within the medical device sector, with demonstrated expertise in handling non-conformance events, CAPA management, Management Review facilitation, and both internal and external auditing
- In-depth knowledge of ISO 13485, EU MDR, FDA regulations, cGMP standards, and Combination Device regulatory requirements
- Possession of Lead Auditor certification or equivalent qualification is strongly preferred.
