Quality Systems Engineer
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 proceduresincluding 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
Über die Firma
