Spring Life Sciences is looking for his client a:
Design Quality Engineer
- Apply knowledge of design, control principles and quality engineering techniques.
- Providing support and guidance for the R&D teams to ensure the design process, design reviews, verification and validation, risk management activities as well as design transfer from R&D to the installation, which are then executed and documented.
- Support the R&D teams, ensuring that the design change control is documented.
- Create Risk Management tools and documents and qualify the employees.
- Generate Standard Operation Procedure and Work Instructions according to 21 CFR 820, 21 CFR 11 and ISO 13485 requirements.
- Support the evaluation and validation of product and process test methods together with the Quality Engineer Process.
- Support the Document Control to generate Standard Operation Procedure, Work instruction as well as formulary.
- Review verification and validation documentation to ensure regulatory requirements and quality objectives are met.
- Support the R&D Team to generate and close NC, CAPAs supervise these deviations true the whole design process (Risk Management).
- Ensure that all topics are according to 21 CFR 820, 21 CFR 11 and ISO 13485 requirements, and follow internal processes, procedures, forms and templates.
- Experience with Quality Engineering, Manufacturing Engineering, and/or Engineering design.
- Experience with Quality Management System (QMS).
- Experience with electronics assembly, machining, and mechanical assembly operations.
- Experience with statistical tools.
- Strong analytical and problem-solving skills.
- Good communication skills.
- Experience with ISO 13485 and 21 CFR 820 compliance and implementation.
- English and French
Are you interested in this job? You can apply directly online, or by eMail.
Please mention reference JN -052019-295984 in your application