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.
Executive 2 - Quality ControlCompany: B. BRAUN MEDICAL IND.
S/B
Functional Area: Quality
Working Model: Hybrid
Requisition ID: 380
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.
Monitor the performance of equipment and processes; identify, troubleshoot and resolve scheduling problems in order to maintain efficient operations.
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.
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.
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.
Investigate out of specification test results with immediate feedback to Supervisor for subsequent action.
Initiate or participate in quality improvement projects/activities, cross function task force in case the needs arise.
Authorized in the absence of the Supervisor to: a) verify and release Final Release Report for finished products.
b) approve Certificates of Conformance, test specifications / method, change control and risks analysis.
c) approve final control holdback NCIR.
d) approve SAP Master data change request.
Issue holdback NCIR/ CAPA request/ CAPA in the absence of the assigned person in charge.
Review complaint report/ investigation in the absence of the assigned person in charge.
Involve in meetings related to the area of responsibility.
Liaise with B Braun affiliates on new test specification or procedure generation or harmonization.
Issue Z2 & C3 notifications upon receive incoming material related complaints from area of responsibility.
Initiate CAPA request/ CAPA based on Z2/C3 trending.
In the absence of assigned personnel for DHR: Responsible to check for completeness of DHR documentation (all test reports, shop packets and production checklist).
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.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Requirements:
Bachelor Degree in Engineering / Science or equivalent.
Knowledge of Quality Management Systems related to Medical Devices, eg.
: ISO13485, MDSAP, 21 CFR Part 820, GMP.
Experience of implementing quality plan and company's quality management system for IPQC section.
Experience of handling in-process non-conforming issue related to production quality issue with knowledge in FMEA, SPC, root cause analysis and six sigma methodologies.
Experience of updating procedures, work instructions and test inspections in the area of responsibility and ensure concurrent update of MES master data to the current test specifications and verify its correctness.
Experience of initiating or participating in quality improvement projects/activities, cross function task force in case the needs arise and understanding of data analysis/statistical methods.
Experience in supervising, coaching, and mentoring 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.
Preferably those with experience in conducting regular audits and assessments to identify areas for improvement.
Preferably having experience in handling internal and external audit.
Implement effective corrective action.#J-18808-Ljbffr