Senior Quality System Engineer

5 days ago

Singapore BECTON DICKINSON MEDICAL (S) PTE LTD Full time

**Who We Are**

**Position Summary**

**Key Responsibilities**
- Manage the document control staff and lead the various Quality System improvement activities in department.
- Responsible for coordinating, writing, reviewing, and providing inputs for Quality System documents to ensure compliance with corporate, QSR, ISO and EN requirements.
- Leads the Quality Internal Audit (QIA) program. Coordinate and implement the corporate process improvement initiatives at site level. Lead the organization in third-party quality audits, ensure availability of documentation by following war-room concept, closes the loop with external auditors on audit reports, action plan, etc.
- Responsible for preparation of Quality Management Review material, prepares and shares meeting minutes and action items. Ensure timely completion of action items from management review.
- Lead the training process to ensure the compliance and implement improvements to overall training process. Develop and delivers different Quality System related, ECM and DMS trainings and guidance to organization including troubleshooting and issue escalation.
- Responsible for governance of the Engineering change management process to ensure accuracy, efficiency, and compliance.
- Responsible to collect, analyse and distribute the Quality system data to demonstrate the suitability, adequacy, and effectiveness of the quality management system.

**Our Requirements**:

- Bachelor’s degree in engineering or related science discipline
- Certified as a ISO13485 Lead Auditor.
- With 5 years relevant experience in quality management system and GDP compliance
- Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, FDA, QSR, etc.)
- Good understanding of QA principles, concepts, industry practices, and standards. General knowledge of related technical disciplines.
- Disciplined and well-organized in documentation
- Team player with excellent interpersonal and communication skills
- Proven ability to work independently with a minimum of supervisor input

**Culture and Benefits**

Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

**How To Apply

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