Sr. Engineer I, Quality Engineering

Quasar Medical; Singapore; Hybrid; SGD 70,000 - 110,000; Full time

Job summary

Quasar Medical in Singapore is seeking a Sr. Engineer I, Quality Engineering to ensure quality and regulatory compliance across manufacturing of medical devices. You will develop QA plans, oversee production, and support new product transfers.

You will lead quality initiatives, participate in audits, investigate deviations, and drive continuous improvement with cross-functional teams. The role requires a degree in engineering or science and 2–5 years in quality, fluent English, and strong

Qualifications

• Degree in Engineering or Science with 2–5 years in quality roles.
• Diploma in Engineering or Science with >5 years in QA may be considered.

Responsibilities

• Develop and maintain QA plans, procedures, and control measures.
• Monitor production processes to detect quality issues.
• Support audits and regulatory inspections (FDA, ISO 13485).
• Lead investigations into deviations and implement CAPA.
• Ensure traceability and documentation throughout manufacturing.

Job description

## Sr. Engineer I, Quality EngineeringApply: Singapore, Singapore: Full time: Posted Today**Our Culture** We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need. Job Summary:• The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process. This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations. This will include support for new product transfers.Essential Duties and Responsibilities:• 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.• 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• 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.• 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.• Train manufacturing staff on quality standards, procedures, and best practices.• Promote a culture of quality and continuous improvement within the organization.Authority:• To approve process / product related forms, work instruction and procedures.• To approve the risk assessment file.• Authorize to sign on the Certificate of Analysis.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 may be considered.• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.• Good command of English language.• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.• Able to effectively collaborate with cross-functional teams and present information clearly.Work Environment:• Controlled Environment (Class 10K/100K cleanroom) and office area.