Engineer II, QMS

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

Quasar Medical (Singapore) pte.ltd. is seeking a Quality System Engineer to drive the Quality System activities in Singapore operations, supporting new product development and transfers with emphasis on traceability and document control.

The role ensures compliance with ISO13485, GMP and FDA CFR Part 820, while collaborating across functions to strengthen quality processes and drive continuous improvement in a regulated medical device environment.

Qualifications

• Degree in Engineering or equivalent; 3–5 years of quality responsibility, preferably in medical devices.
• Excellent communication skills and strong documentation practices.
• Proficiency with FMEA, DOE, SPC and QMS/GMP writing standards.
• Knowledge of ISO9001, ISO13485, FDA 21 CFR Part 820 and medical device directives.

Responsibilities

• Support QMS processes including Non-Conformance, Internal Audit, CAPA, SCAR, Change Plan, RMA and related activities.
• Maintain quality system processes to stay compliant with quality/regulatory requirements.
• Ensure awareness of customer and regulatory requirements; develop awareness programs.
• Highlight and recommend improvements to the site QMS.
• Assist investigations and analysis of customer complaints.
• Support NPD and transfer activities from a quality system perspective.
• Assist HR with new employee induction on documentation standards.
• Support site quality projects and audits, both external and internal.
• Compile weekly/monthly site metrics and reports for management.
• Develop, revise documentation procedures and maintain all required documents.
• Train personnel on documentation standards and practices.
• Maintain compliance with ISO13485, GMP and FDA CFR Part 820.

Skills

FMEA

DOE

SPC

Quality Assurance

Regulatory knowledge

GMP

ISO13485

Education

Bachelor's degree in Engineering

Diploma in Engineering

Tools

QMS software

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 System Engineer is responsible for the Quality System activities within Quasar Singapore Operations. This will include support for new product development and transfers. Responsible for assuring that quality documents and records within Quasar Singapore Operations are identified, collected, implemented, revised, indexed, filed, stored and maintained in a manner, which ensures traceability, integrity and accessibility.

Essential Duties and Responsibilities

• Support of site quality system processes-QMS, Non-Conformance, Internal Audit, Complaints handling, CAPA, SCAR, Change Plan, RMA, etc.
• Maintain quality system processes to ensure that they remain relevant and compliant to applicable quality and regulatory requirements.
• Ensure that site is aware of all customer and applicable quality & regulatory requirements. Create awareness programs where required.
• Highlight & recommend any improvement to the site QMS.
• Assist in the investigation and analysis of customer complaints.
• Support new product development and transfer activities from quality system perspective.
• Support new employee induction program by HR.
• Support site initiatives/ projects related to the quality system.
• Assist in all external customer and quality system audits.
• Assist in internal auditing of the Quality System.
• Compile weekly and monthly site metrics / reports to management.
• Develop, enhance, and revise documentation procedures, implements necessary updates, and maintains all required documents as defined by applicable regulations.
• Train relevant personnel on documentation standards and practices.
• Maintain and comply with ISO13485, GMP and FDA CFR Part 820 requirements.

Authority

• NA

Education/Experience and Qualifications

• Degree in Engineering or equivalent, with 3-5 years of progressive quality responsibility, preferably in medical device manufacturing.
• Diploma holders in Engineering or equivalent with over 5 years of relevant experience may also be considered.
• Excellent communication skills.
• Demonstrated proficiency in use of engineering tools-FMEA, DOE, SPC, etc.
• Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
• Knowledge of ISO9001, ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives.

Work Environment

• While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts.
• The noise level in the work environment is usually moderate.
• 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. Check out our open positions and bring your passion to life.

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. Explore exciting career opportunities with Quasar by browsing our current job openings. We look forward to hearing from you!

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. If you share our commitment to quality and innovation, we want to hear from you.