Quality Engineer

5 days ago

Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

**JOB SUMMARY**: The Quality Engineer is responsible for the product quality activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers. **ESSENTIAL DUTIES AND RESPONSIBILITIES**: Include the following. Other duties may be assigned. - Maintain and comply with the requirements of ISO13485, GMP, FDA 21 CFR Part 820 and other applicable regulations. - Participate in the internal and notified body audit programs as required. - Management of MRR activities. - Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections, - Ensure that non-conforming products are properly handled via Non-Conforming Materials Review (NCMR) process. - Establishing inspection standards, plans, frequencies and test methods. - Lead and drive QA initiatives across the product areas. - Support and drive cost improvement project - Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence. - Drives robust and effective corrective and preventive action programs through the CAPA system. - Strategically lead new product introduction from a QA perspective. - Overall responsibility for production GMP standards and compliance, also including cleanroom requirements. - Participate in new product introductions to ensure quality is built into all products early in their life cycle - Support Production on all quality-related activities, including working closely with Engineering and other applicable functions. - Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner. - Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions. - Supervision and direction of other Quality personnel. - To support audits from customers and external regulatory agencies (FDA, BSI etc) - Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate. **EDUCATION/ EXPERIENCE AND QUALIFICATIONS**: - Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years' relevant experience may be considered - Excellent communication & project management skills. - Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc. - Knowledgeable in writing manufacturing procedures to QMS/GMP requirements. - Knowledge of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives. - Proven abilities in decision making and sound personal judgement. Good organization, supervisory and investigation skills are required. - Proven ability to influence. **WORK ENVIRONMENT**: While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment (Class 10K/100K cleanroom) and office area.

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