Quality Engineer

2 days ago

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

The Lead Quality Engineer is responsible to lead the team of product quality engineers and Quality Operations activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers. Maintain and comply with the requirements of IS013485, 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. Lead 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. Lead 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 IS013485, 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. Experience in Sterilization (ETO) is preferred. Not Specified

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