Quality Engineer - Singapore - QUASAR MEDICAL (SINGAPORE) PTE. LTD.

QUASAR MEDICAL (SINGAPORE) PTE. LTD.
QUASAR MEDICAL (SINGAPORE) PTE. LTD.
Verified Company
Singapore

4 weeks ago

Wei Jie

Posted by:

Wei Jie

beBee Recruiter
Description

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/ inprocess/ outgoing quality inspections,
  • Ensure that nonconforming 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 reoccurrence.
  • 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 qualityrelated activities, including working closely with Engineering and other applicable functions.
  • Assist in the investigation and analysis of customer complaints and followup 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 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.
More jobs from QUASAR MEDICAL (SINGAPORE) PTE. LTD.
See all jobs of QUASAR MEDICAL (SINGAPORE) PTE. LTD.