Senior Quality Systems Engineer
2 weeks ago
Job Description Summary
**Job Description**:
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
Primary Work Location
SGP Tuas - Tuas
Additional Locations
Work Shift
-
Senior/ Engineer, Quality
2 weeks ago
Tuas, Singapore REC Group Full timeCOMPANY DESCRIPTION REC Group is an international pioneering solar energy company dedicated to empowering consumers with clean, affordable solar power through high-quality solar panels with a leading power density. As Solar's Most Trusted, REC is known for its patented innovations and multiple award-winning products with reliable long-term performance. The...
-
Senior/ Engineer, Quality
1 week ago
Tuas, Singapore REC Group Full timeCOMPANY DESCRIPTION REC Group is an international pioneering solar energy company dedicated to empowering consumers with clean, affordable solar power through high-quality solar panels with a leading power density. As Solar's Most Trusted, REC is known for its patented innovations and multiple award-winning products with reliable long-term performance. The...
-
Engineer, Quality Systems
1 week ago
Tuas, Singapore Kuok (Singapore) Limited Full time**Engineer, Quality Systems at PaxOcean Singapore Pte Ltd (Based in Tuas)**: This role ensures compliance with ISO 9001:2015 by maintaining and improving the Quality Management System (QMS). Responsibilities include managing QMS document revisions, audits, supporting continual improvement initiatives, conducting quality training, analysing quality data, and...
-
Quality Engineer
2 weeks ago
Tuas, Singapore BD Singapore Full timeJob Description Summary **Job Description**: We are the makers of possible BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
-
Senior Engineer
2 weeks ago
Tuas, Singapore Alcon Full time1st level engineering support for SCADA downtime [24x7 supports] - Focus on solving recurring/ long-term system issues through detailed understanding of the design or engineering concepts. - Lead and support automation/control related projects. Develop/review project documentations and related SOPs. Perform equipment/software validation. - Prepare training...
-
Senior Process Engineer
4 days ago
Tuas, Singapore Pfizer Full timeWill be responsible for leading product manufacturing campaigns from the start of production and providing technical supervision with respect to quality and EHS until completion and release of the material. POSITION RESPONSIBILITIES - Develop Manufacturing/Operating Instructions and necessary Standard Operating Procedures. - Develop, maintain and...
-
Senior Quality Engineer
1 week ago
Tuas, Singapore BD Singapore Full timeJob Description Summary **Job Description**: We are the makers of possible BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
-
Quality Assurance Engineer #54875
2 weeks ago
Tuas, Singapore Anradus Pte Ltd Full timeIndustry/ Organization Type: Heavy industrial/ Machinery - Position Title**:Quality Assurance Engineer/ QA Engineer**: - Working Location: Tuas (Transportation provided from Jurong West area) - Working Hours: Monday to Friday, 8.30 am - 6 pm - Salary Package**:Up to $3200 + OT + Bonus**: - Duration: Permanent **Key Responsibilities** - Test current...
-
Quality Engineer
10 hours ago
Tuas, Singapore Superform Consulting Pte Ltd Full timeJob Title: Quality Engineer Location: Tuas Working Days: Mon -Fri Working Hours: 7.45 AM-4.45 PM **Salary**: Basic up to $4500 Job Duties: - Develop and implement procedures as required by the standards and regulatory requirements for process and product control to ensure product and process validation are compliant with cGMP, FDA 21 CFR Part 820, Part...
-
Quality Engineer
2 days ago
Tuas, Singapore XIN MING HUA PTE LTD Full time3 years exp **Roles & Responsibilities** - Work closely with the Engineering and Production team to develop incoming quality, in-process Quality and Outgoing Quality requirements - Responsible for all Quality plans of all products to meet customers specifications - Work with relevant agencies to adhere to certification requirements when required - Work with...
