Engineer/ Senior Engineer - Quality Management

Job Title: Quality Management Engineer

Responsibilities:

• Follow established engineering principles to determine the sequence of steps or processes required to fabricate and assemble products that meet the organization's standards of quality and cost.
• Analyze product specifications, part drawings, and other engineering data to develop recommendations for changes to working methods or operations sequence that will minimize risks and improve the quality and consistency of final products.
• Involve in continuous improvement/kaizen/lean projects and meetings, and coordinate quality improvement activities within the area of responsibility.
• Coordinate Verification Matrix establishment activities with respective CoE.
• Collect, analyze, and summarize data to identify cause analysis to provide in-depth descriptions of manufacturing anomalies.
• Initiate NCIR/CAPA/CAPA requests for holdbacks and customer complaints based on CAPA SOP and CAPA Initiation Criteria.
• Coordinate QS-Stat training for the site upon request and review/update SOP related to QS-Stat.
• Coordinate evaluation of harmonizing amongst inline tests, IPQC, and FC to ensure effective and cost-optimized quality control inspections.
• Coordinate activities related to measurement system analysis (MSA) of test, inspection, and measuring equipment within the area of responsibility.
• Train and coordinate activities related to test method verification/validation.
• Involve in respective plant projects relevant to the area of responsibility such as SPC implementation.
• Communicate problems clearly to staff and team members of different technological backgrounds.
• Ensure that the company is in compliance with ISO standards and organize the certification process.
• Coordinate and direct ISO project implementation teams.
• Train key managers and employees on ISO principles and requirements.
• Design continuous improvement and audit processes to ensure continued compliance with ISO and better business procedures.

Requirement:

• Bachelor's degree in any field, preferably in sciences and engineering.
• Good understanding of ISO standards such as ISO 13485:2016, QSR Part 820 CFR.
• Proficient in problem-solving methodology, change control management, and risk management.
• Experience working in quality management; open to candidates from process, equipment, or production fields interested in quality management.

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 | [Confidential Information]