Senior Quality Engineer - Medical Devices & Compliance

Quasar Medical

Singapore

On-site

SGD 70,000 - 110,000

Full time

2 days ago

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Job summary

Quasar Medical is seeking a Quality Engineer to ensure regulatory compliance and quality throughout the manufacturing process. You will develop QA strategies, oversee production, and support new product transfers with a focus on early quality integration.

The role requires strong problem-solving abilities, cross-functional collaboration, and effective communication in English. Experience in medical device manufacturing and ISO 13485 awareness is essential.

Qualifications

Degree in Engineering or science; 2–5 years in QA for medical devices/pharma manufacturing, or Diploma with 5+ years QA experience.
Knowledge of FDA/ISO 13485 and regulatory requirements.
Strong English communication, analytical and problem-solving skills.

Responsibilities

Develop, implement, and maintain QA plans, procedures, and controls.
Monitor production processes to detect quality issues and drive improvements.
Support audits and regulatory inspections and document findings.
Lead root-cause analysis and corrective actions for non-conformances.
Collaborate with customers to understand quality requirements and address feedback.
Oversee documentation and traceability throughout manufacturing.