Asst Staff Engineer - Quality (Machine validation)
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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.
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.
- Where applicable, follow established engineering principles to determine the sequence of steps or process required to fabricate and assemble products that meet the organization's standards of quality and cost.
- Where applicable, analyse product specifications, part drawings and other engineering data to develop new production processes and develop recommendations for changes to working methods or operations sequence that will minimise risks, cost and wastage; increase yields and productivity; and improve the quality and consistency of final products.
- Where applicable, involve in continuous improvement/kaizen/lean projects and meetings and coordinate process improvement activities within area of responsibility
- Where applicable, coordinate Verification Matrix establishment activities with respective CoE.
- Where applicable, update holdback listing and initiate NCIR/CAPA/CAPA request for holdbacks.
- Where applicable, coordinate QS-Stat training for site upon request and review/update SOP related to QS-Stat.
- Where applicable, coordinate & develop URS for software validation within area of responsibility.
- Where applicable, coordinate evaluation of harmonizing amongst inline tests, IPQC and FC to ensure an effective and cost optimized quality control inspections.
- Where applicable, coordinate activities related to time studies of processes within area of responsibility.
- Where applicable, coordinate activities related to measurement system analysis (MSA) of test, inspection and measuring equipment within area of responsibility.
- Where applicable, train and coordinate activities related to test method verification/revalidation.
- Where applicable, involve in respective plant projects relevant to area of responsibility such as SPC implementation.
- The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.
Requirements:
- Bachelor’s degree in Engineering/Science.
- Experience in project management, validation, and calibration.
- Good experience in machine handling - test method, test analysis, handling of equipments.
- Proficiency in Microsoft Power Apps, Power Automate (Flow), and Power BI..
- Strong reporting skills (daily, weekly, monthly)..
- Excellent presentation skills.
- Knowledge of preventive maintenance planning.
- Experience in a medical device manufacturing environment.
- Experience with automation and process improvement projects.
- Certification in Quality Management Systems.
B. BRAUN MEDICAL IND. S/B | Samantha Chua | +604-6324679
