Quality Systems Engineer

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Batu Kawan, Selatan, Pulau Pinang
1-3 Years Experience
Healthtech
The Role

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Job summary

Responsible for performing customer complaint investigation, laboratory test procedures to support production in the process of approving product release; accountable to analyze and assess trends, recommend new or improved procedures including the thorough, validation of new processes and on-going monitoring of systems and equipment.

Essential duties

  • Responsible to analyze and evaluate the customer complaint return sample and drive the corrective action.
  • Responsible for ethylene oxide and gamma sterilization validation and re-validation.
  • Responsible to review and approve sterilization certificate, bacterial endotoxin test certificate and particulate test certificate.
  • Responsible to review, analyse and prepare reports for environmental monitoring test, product bioburden test, and other microbiological tests.
  • Responsible to perform airborne non-viable particulate test, airborne viable and surface viable test in the plant-controlled work zones.
  • Responsible to coordinate sample collection and sample delivery to testing labs.
  • Ensure the complete and accurate documentation and reporting for all microbiological tests
  • Responsible to review and approve FMCS, FMS and datalogger trend chart.
  • Participate in problem solving and other work improvement activities.
  • Reviews all tests results and determines acceptability or initiate and conduct further investigation – including additional testing, root cause analysis, conclusions summarized in written records.
  • Participates in all third-party audits as subject matter expert.
  • Perform other tasks as required.

Job Requirement

  • Degree in Life Science discipline or equivalent. Prefer with equivalent experience, other college major with some college level course work in Biology or Microbiology.
  • Minimum 2 years working experience in manufacturing environment will be an added advantage.
  • Minimum 1 year laboratory experience will be an added advantage.
  • Fresh graduate who are participating in MedTech Talent and Employment program are encouraged to apply.
  • Knowledge in problem solving, root cause and statistical Analysis.
  • Knowledge in Oracle ERP system will be an added advantage.

EEO Policy Statement

The Company
HQ: Boston, MA
1,993 Employees
On-site Workplace
Year Founded: 1971

What We Do

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.

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