Sr. Engineer I, Quality Engineering

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

Quasar Medical (Singapore) pte.ltd. is seeking a Quality Engineer to safeguard the quality and regulatory compliance of our medical devices throughout the manufacturing process.

You will develop QA strategies, monitor production, and support new product transfers to ensure standards are met from design to final release. The role requires 2–5 years of progressive QA responsibility in medical device manufacturing, knowledge of FDA regulations and ISO 13485, and strong analytical and communication

Qualifications

• Degree in Engineering or science with 2–5 years QA experience in medical devices.
• Knowledge of FDA regulations and ISO 13485.
• Strong English communication and teamwork skills.

Responsibilities

• Develop, implement, and maintain quality assurance plans and controls.
• Monitor production processes to detect quality issues.
• Ensure compliance with FDA, ISO 13485, and relevant standards.
• Support internal and external audits and regulatory inspections.
• Investigate non-conformities and drive corrective actions.
• Lead quality improvements and training for staff.

Skills

Quality assurance

Regulatory compliance

Analytical skills

Cross-functional collaboration

Problem-solving

Education

Engineering or science degree

Job description

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.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority – it is part of our culture.

Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously.

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally.

What we make saves lives.