Engineer II, QMS

Quasar Medical; Singapore; Hybrid; SGD 60,000 - 90,000; Full time

Job summary

Quasar Medical Singapore is seeking a Quality System Engineer to oversee QMS activities, support new product development and transfers, and ensure traceability and compliance of quality documents and records.

The role requires 3–5 years in medical device quality, proficiency in FMEA/DOE/SPC, and knowledge of ISO9001/ISO13485 and FDA 21 CFR Part 820. Strong communication and coordination with HR and site management are essential.

Qualifications

• Degree in Engineering or equivalent; 3-5 years quality experience.
• Diploma in Engineering or equivalent with 5+ years experience.

Responsibilities

• Support QMS, Non-Conformance, Internal Audit, Complaints handling, CAPA, SCAR, Change Plan, RMA.
• Maintain and ensure compliance with ISO9001, ISO13485, FDA CFR Part 820 requirements.
• Assist in external customer and quality system audits; prepare site metrics.

Skills

FMEA

DOE

SPC

Communication

Education

Degree in Engineering or equivalent

Diploma in Engineering or equivalent

Job description

## Engineer II, QMSApply: 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 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:• NAEducation/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.