senior / product quality manager (pcb & fda audit) in Singapore

posted
contact
yit wei kwan, randstad
job type
permanent
salary
S$ 8,500 - S$ 13,000 per month

job details

posted
location
singapore
specialism
manufacturing & production
job type
permanent
working hours
Full-Time
salary
S$ 8,500 - S$ 13,000 per month
experience
8 years
reference number
91M0158004_1626081874
contact
yit wei kwan, randstad
phone
65103642
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job description

about the company

My client is an USA MNC specializing in the design and production of a wide range of high medical products.The business succeeds on the speed of its innovation and there are great opportunities to progress in this dynamic company.

about the job

  • Lead supplier selection and qualification activities in the Asia Pacific region
  • Responsible for Site Quality Compliance initiatives
  • Manage field response rate and ensure corrective actions are implemented throughout manufacturing site
  • Drive Global Supplier Quality Metric review
  • Responsible for Products Quality to conform to specifications
  • Support and Involved in Internal Audits, ISO9001, ISO13485 and GMP compliance/ FDA Certification

skills & experience required

  • Master / Bachelor Degree in Science / Quality / Electrical / Mechanical Engineering or equivalent
  • Min 10 years’ of experience in PCB / PCBA product quality manufacturing environment
  • Proficient with the FDA 21CFR Part 820 Quality System Regulation,Medical Device Directive (MDD)and ISO13485 Quality System Standards
  • Experience with Class II & III devices
  • Experience in managing and conducting a full FDA audit
  • Able to reach technical drawings will be a plus
  • Proficient in handling customer complaints and CAPA

If you are interested in the position , kindly send your CVs in to yitwei.kwan(@)randstad.com.sg

Please include your availability , expected salary and reason for leaving current job.

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913

skills

FDA

qualification

Degree

educational requirements

Bachelor Degree