Quality Engineer

2 months ago


Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time
Roles & Responsibilities

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

  • Develop, implement, and maintain quality assurance plans, procedures, and control measures.
  • Monitor and analyse production processes to detect and resolve quality issues.
  • Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
  • Support internal and external audits and regulatory inspections.
  • Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
  • Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle
  • Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

  • Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
  • Lead and drive QA initiatives across the product areas
  • Lead or participate in root cause analysis and corrective action planning.
  • Support and drive cost improvement project

3. Customer Interaction:

  • Address customer complaints and feedback related to product quality.
  • Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
  • Communicated on any potential change request of the processes to customer.
  • Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

  • Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
  • Prepare and support monthly / annual quality reports to management and other stakeholders.
  • Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

  • Train manufacturing staff on quality standards, procedures, and best practices.
  • Promote a culture of quality and continuous improvement within the organization.


Education/Experience and Qualifications:
  • Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
  • Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
  • Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
  • Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

Tell employers what skills you have

Management Skills
CAPA
FDA
Quality Control
FMEA
Quality Management
Process Improvement
Quality Assurance
ISO
GMP
Investigation
Process Validation
Compliance
Project Management
SPC
Audits
Decision Making
Manufacturing
Audit
Technical Support

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