Senior Quality Technician - 6 Months Contract
ONWARD Medical
The Senior Quality Technician will be responsible for executing quality control activities and ensuring compliance with quality and regulatory standards to uphold the highest levels of product quality and safety. This role offers an exciting opportunity to contribute to the development and maintenance of quality systems within a dynamic and innovative company.
Responsibilities
- Manage product reception.
- Proceed with incoming inspection activities.
- Initiate non-conformities observed during incoming inspection and report them through the appropriate document and channel.
- Manage product return to supplier (informatic and physical).
- Responsible for the Quality storage area (quarantine and release zone).
- Manage the work order preparation (milkman) and the associated paper document (travelers, traceability document).
- Ensure operators are trained on internal procedure for Quality and Manufacturing.
- Perform DHR review (GDP compliance, traceability information, Nc’s).
- Accountable for final product release with Quality representative.
- Participate in continuous improvement related to component / sub-assemblies / finished products and associated processes. Participate in supplier quality management activities as required with Supplier Quality Engineer.
Experience, Qualifications & Skills
- Bachelor's degree or equivalent in a relevant scientific or engineering discipline
- Proven experience (5 to 10 years) in Quality Control in the medical devices industry.
- Proficiency in conducting inspections, tests, and analyses using various quality control tools and techniques.
- Knowledge of quality management systems (ISO 13485, FDA QSR) and regulatory requirements for medical devices.
- Good understanding of technical drawing reading.
- Strong Manufacturing technical knowledge.
- Good commend of informatic tools (Microsoft, ERP, SAP…).
- Excellent communication and interpersonal skills, with the ability to work autonomously with strong rigor and flexibility.
- Strong teamwork approach and optimism with analytical and synthetic spirit.
- Fluent level of English, French would be a plus.
Supervision
Individual contributor.