Quality Controllers

2 weeks ago


Penang, Malaysia B. Braun Medical Ind. Sdn. Bhd. Full time

**Duties and responsibilities**:

- Perform the following in their respective area of responsibility which may include the following:

- Perform incoming/ in-process/ final test/inspection of products/ materials based on approved test specifications, test methods, procedures, working instructions, equipment operating instruments and guidelines (where applicable).
- Perform SAP results recording of test/ inspections.
- Notify superior immediately upon out of specification test results for subsequent actions.
- Where applicable, responsible for filing, compilation and documentation of test report, relevant documentation of all test conducted and quality batch records.
- Where applicable responsible for compilation of DHR documentation (all test reports, shop packets and production checklist) for final release.
- Issue appropriate stickers and holdback / information form (where applicable) based on the status of the product/materials.
- Issue Holdback Notification to production upon batch failure.
- Handle tasks related to QC function as and when assigned by the superior.
- Ensure that all QC related matters are reported to the superior.
- Ensure error free test reports including checking of record completeness.
- Filing, archiving and retrieval (upon request) of records/ documents/ DHR in area of responsibility.
- For DHR QC only:

- Perform routine final release User Decision - Accepted or Rejected transaction in SAP upon approval of QC HOD or authorized person as assigned.
- Where applicable for assigned DHR QC only:

- Perform trouble shooting of SAP master data error and SAP master data update related to QC functions in the absence of the assigned personnel in charge.
- Where applicable, execute the QC responsibilities as described in SOP Handling of Scap in the IMS.
- For Incoming QC only - Where applicable the assigned QC is requested to perform Usage Decision upon accept/reject
- transaction in SAP in the area of responsibility in the absence of the person in-charged or during high volume of incoming
- materials as additional support to the person in-charged.

**Professional competencies**:

- SPM/SPVM with basic working experience.
- Knowledge of ISO 13485.
- FDA 21 CFR Part 820.
- On the job training for new employees on probation. Work performed within a narrowly defined parameter.
- Works under immediate supervision.

**Personal competencies**:

- Learn actively.
- Deliver Performance & Results.

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 2024-05-31



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