Senior Quality Engineer
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Job Summary
- Lead quality planning activities for new projects establish product line quality control plans and develop inspection standards for raw materials in-process stages and finished goods.
- Perform in-process and final product inspections; compile inspection and batch production records; conduct compliance reviews; and ensure Device History Records (DHR) are complete accurate traceable and properly archived.
- Maintain proper product inspection status control and ensure timely and appropriate disposition of non-conforming or held products.
- Carry out routine GMP compliance inspections within cleanroom environments and drive adherence to GMP standards in cleanroom operations.
- Facilitate cross-functional quality meetings to conduct root cause analysis on issues such as non-conforming products quality incidents customer complaints and adverse events; develop corrective action plans and monitor the closure of NCR and CAPA activities.
- Conduct periodic statistical analysis of product line quality performance and recommend continuous improvement initiatives.
- Participate in internal quality audits and assist in external audits conducted by customers and regulatory bodies.
- Train QC personnel on raw material in-process and finished product inspection standards methodologies and equipment operation to ensure independent and accurate execution of inspection activities.
- Deliver company-wide training on product inspection requirements process compliance and overall quality awareness.
- Undertake additional responsibilities assigned by the department head and collaborate effectively with cross-functional teams to ensure project objectives are achieved.
- Bachelors degree or above in Chemistry Biology Pharmaceutical Sciences Food Science Electronics Mechanical Engineering or a related discipline with a minimum of 5 years experience in quality control and quality management within medical device manufacturing particularly involving sterile or metallic implants.
- Knowledgeable in cleaning validation cleanroom control and on-site supervision preparation of inspection documentation and batch record review processes.
- Well-versed in quality management systems with ISO 13485 Internal Auditor certification.
- Familiar with regulatory standards for sterile medical devices and experienced in operating inspection equipment such as optical measuring instruments and tensile testing machines.
- Proficient in new product development workflows and validation processes with a strong understanding of risk management principles and practices.
- Experienced in utilizing quality methodologies and tools including the Seven QC Tools Five Core Quality Tools and Minitab software to support quality improvement initiatives.
- Detail-oriented accountable and analytical with strong logical reasoning and structured problem-solving capabilities.
- Demonstrates strong cross-functional collaboration and cross-cultural communication skills with fluency in English and Mandarin across listening speaking reading and writing.
Required Skills:
Lead quality planning activities for new projects establish product line quality control plans and develop inspection standards for raw materials in-process stages and finished goods. Perform in-process and final product inspections; compile inspection and batch production records; conduct compliance reviews; and ensure Device History Records (DHR) are complete accurate traceable and properly archived. Maintain proper product inspection status control and ensure timely and appropriate disposition of non-conforming or held products. Carry out routine GMP compliance inspections within cleanroom environments and drive adherence to GMP standards in cleanroom operations. Facilitate cross-functional quality meetings to conduct root cause analysis on issues such as non-conforming products quality incidents customer complaints and adverse events; develop corrective action plans and monitor the closure of NCR and CAPA activities. Conduct periodic statistical analysis of product line quality performance and recommend continuous improvement initiatives. Participate in internal quality audits and assist in external audits conducted by customers and regulatory bodies. Train QC personnel on raw material in-process and finished product inspection standards methodologies and equipment operation to ensure independent and accurate execution of inspection activities. Deliver company-wide training on product inspection requirements process compliance and overall quality awareness. Undertake additional responsibilities assigned by the department head and collaborate effectively with cross-functional teams to ensure project objectives are achieved.
Required Education:
Bachelors degree or above in Chemistry Biology Pharmaceutical Sciences Food Science Electronics Mechanical Engineering or a related discipline with a minimum of 5 years experience in quality control and quality management within medical device manufacturing particularly involving sterile or metallic in cleaning validation cleanroom control and on-site supervision preparation of inspection documentation and batch record review processes.
