Regulatory Affairs jobs in France

The QC technician is responsible for supporting quality activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers.

• Inspect and test incoming raw materials, components, and packaging materials using established procedures.
• Conduct in-process and final product inspections, including dimensional checks, functional testing, and visual inspections.
• Operate and maintain QC instruments (e.g., calipers, micrometers, microscopes, tensile testers).
• Record test data accurately and ensure traceability in compliance with GDP (Good Documentation Practices).
• Establish test methods and train QC inspectors to perform testing.
• Complete inspection records, test reports, and nonconformance reports in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Ensure proper labeling, segregation, and disposition of accepted/rejected materials.
• Assist in investigation of nonconformities, deviations, and customer complaints.
• Support CAPA and change control processes.
• Collaborate with production to maintain in-process quality.
• Audit production line to ensure GMP practices and adherence to documented process instructions.
• Escalate quality issues to QC Supervisor/Quality Engineer for disposition.
• Participate in equipment calibration and preventive maintenance programs.
• Support process validations and verification activities.
• Contribute to improvement of inspection methods and sampling plans.
• Provide feedback to engineering and production teams on quality issues and trends.
• Participate in internal audits, training, and quality improvement initiatives.

• GCE “O” level or equivalent, Diploma preferred.
• 1–2 years of progressive Quality responsibility preferably in Medical Device / Pharmaceutical Manufacturing.
• Excellent communication skills; English written & oral communication skills are a must.
• Knowledgeable in reading and/or writing manufacturing procedures and GMP requirements.
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards is a plus.
• Willingness to work in a multicultural team and in a clean room environment.