Manager, Qc Operation

**Position Summary**
- Responsible for providing technical guidance (including the device mechanical/functional aspects, drug related pharmaceutical requirements and equipment/software requirements) and supervisory leadership to overall QC operation, including Incoming QC (IQC), In-Process QC (IPQC), Lot Release QC (IPQC) and Outgoing QC (OQC). To ensure adequate resources planning to meet test support demands, and smooth, timely execution of the assigned routine testing activities for raw material, subassemblies, and Final Goods (FGs) release as well as to support non-routine testing activities for monitoring, validation, and engineering studies. And responsible for overall supervision of the OQC to ensure inspections are carried out timely for all Return Goods (RGA), FG rework/conversion, and 3rd party product inspection within the tight deadline.
- Manage QC team and set quality standards to ensure that operations comply with the requirements of QMS, reference standards for all the applicable regulation in the markets we serve, including ISO 13485, MDR, FDA 21 CFR 820/211, Japan MHLW etc. and responsible for the overall product quality.
- Established and maintain the documented procedures for QC testing/measurement. Maintain personnel competency to achieve the valid quality decision outcome. In addition, maintain the stability and validity of measurement equipment’s/tools for operational excellence, quality compliance and fulfil business needs on sale demands.
- Accountable for financial and budgetary oversight of the department (QC operations).
- Accountable for the external/internal audit, and follow up systematically in the post-audit findings by effectively implement the changes within the given period.

**Position Responsibilities**
- Provide overall supervision of IQC, IPQC, LRQC and OQC operations, and technical leadership/guidance on the device mechanical/functional aspects, drug related pharmaceutical requirements and equipment/software requirements to fulfil quality compliance.
- Establish training plan for new joiner and maintain the training competency and proven training effectiveness of the existing personnel.
- Oversee the team of inspectors/lab support, technicians for day-to-day functions to support the on-time delivery of good quality product to the market, and review the performance of the personnel.
- Work out QC capacity plan, human and material resources needed to meet the sales demands.
- Responsible for the overall equipment and analytical instrument management. Maintain the validity of measurement equipment’s/tools through calibration, verification and revalidation at the specific interval. Ensure no equipment downtime, which will directly affect the QC operational activities.
- Maintain and initiate the improvements QC inspection/testing procedure and test equipment to achieve maximum efficiency and cost-effectiveness.
- Strong analytical skills and judgement to interpret test data. Review and approve test reports, and lot release forms and ensure timely release of the materials, components and finished goods.
- Responsible for the product quality and monitor the materials, components and finished goods quality performance, work with various process owners to investigate and resolve non-conformities or CAPA encountered and initiating correction action and preventive action as needed.
- Ensure complete compliance of QMS, cGMP and 5S for all the operational activities.
- Ensure that health, and safety guidelines are followed. And responsible for Environmental Management System (EMS) compliance.
- Perform any other related duties as assigned by superior.
- Maintain QC and the laboratory in audit ready status and support site audits/inspections

**Experiences, Knowledge, Skills and Abilities**
- Minimum a Bachelor Degree in Science or Engineering related disciplines, and Pharmaceutical science, Chemistry or equivalent educational background or experience will be an added advantage.
- At least 5 years relevant experience in QC, QA fields or equivalent, with the ability/experience to understand the principle or operation of the measurement equipment or even analytical instruments.
- In-depth knowledge and understanding on MDD (93/94/EEC)/MDR (2017/745), ISO 13485, 21 CFR 820, 210 & 211
- Knowledge or experience on risk management on ISO 14971 or pharmaceutical exposure will be added advantages
- Good experience of QA/QC and cGMP/GDP/GLP requirements
- Knowledge on Statistical Process Control (SPC) and quality management/analysis/improvement tools
- Leadership experience and peoples management skills
- Excellent interpersonal and communication skill is essential and possess positive attributes
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- High level of integrity
- Able to work under stress, prioritize, and deliver according to schedule