You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Responsibilities :
- Where applicable, plan, coordinate and organize day-to-day activities of a team of Quality Controllers, Quality Supervisors and/or Quality Officers Assurance Operators who check, test and inspect raw materials/ goods in-process/ finished goods or DHR compilation/archival/retrieval in the areas of responsibility.
- Where applicable, monitor the performance of equipment and processes; identify, troubleshoot and resolve scheduling problems in order to maintain efficient operations.
- Where applicable, prepare activity and/or monitor progress/block stock reports so scheduling/ recurring problems, either with the quality of the product or the reliability of testing procedures, can be identified and addressed.
- Where applicable, supervise, coach, and mentor team members/ subordinates; prioritize and assign tasks to ensure that the team's resources are used effectively and that work schedules and targets are met.
- Where applicable, update procedures, work instructions and test inspections in the area of responsibility and ensure concurrent update of SAP master data to the current test specifications and verify its correctness.
- Where applicable, investigate out of specification test results with immediate feedback to Supervisor for subsequent action.
- Where applicable, initiate or participate in quality improvement projects/activities, cross function task force in case the needs arise.
- Where applicable, authorized in the absence of the Supervisor to:
- verify and release Final Release Report for finished products.
- approve Certificates of Conformance, test specifications / method, change control and risks analysis.
- approve final control holdback NCIR.
- approve SAP Master data change request.
- Where applicable, issue holdback NCIR/ CAPA request/ CAPA in the absence of the assigned person in charge.
- Where applicable, review of complaint report/ investigation in the absence of the assigned person in charge.
- Where applicable, involve in meetings related to the area of responsibility.
- Where applicable, liaise with B Braun affiliates on new test specification or procedure generation or harmonization.
- Where applicable, issue Z2 & C3 notifications upon receive incoming material related complaints from area of responsibility.
- Where applicable, initiate CAPA request/ CAPA based on Z2/C3 trending.
- Where applicable, in the absence of assigned personnel for DHR: Responsible to check for completeness of DHR documentation (all test reports, shop packets and production checklist).
- Where applicable, in the absence of assigned personnel for DHR: Responsible to check for completeness Final Release Report (FRR) and perform verification of User Decision transaction in SAP performed by assigned personnel for final release.
Requirements :
- Bachelor Degree in Sciences, Material Sciences o equivalent.
- Experienced in physical testing in laboratory i.e. using tensile machine, leakage tester for packaging.
- Experienced in either Quality Control / Quality Management.
- Knowledge in FDA 21CFR and ISO 13485 requirement will be an advantage.
- Experienced in developing Test Specifications and Work Instructions for Quality Control Operation.
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.
Contact: B. Braun Medical Ind. Sdn. Bhd. | Sheryn | 04-632 4522
