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Quality assurance consultant (m/w/d) (EN)
[13349]
Quality Assurance, QMS, ISO 13485
Job title: Quality assurance consultant (m/w/d) Industry: Medizintechnik Skills: Quality Assurance, QMS, ISO 13485 Start of project: 1.08.2023 Duration of the project : 6 months Project volume: 1008 Hour(s) Location: Geneva, Switzerland I am looking for an experienced Quality assurance consultant to support a Medical device company for a 4 months project. Starting date: August 2023 Responsibility: ·To establish and maintain procedures relative to quality documentation ·To provide support on quality system procedures ·To perform quality assurance review and facilitate the release of production batch ·To manage and monitor of CAPAs and non-conformities ·To participate in the audit, approval of suppliers, ensuring high-quality inputs for manufacturing process. ·To support in the Process Validation activities ·To support in preparing regulatory submissions in Europe and the USA. Knowledge, Skills and Abilities: ·Bachelor’s or Master’s degree in Quality, Mechanical, Biomedical Engineering, or a related field ·Knowledge of quality systems, quality assurance techniques, and regulatory standards (e.g. ISO 13485 and FDA 21 CFR) ·Proficiency in the use of statistical analysis and quality improvement tools ·Proficiency in documenting all work reliably and accurately as per QMS standards ·Minimum 4 years of experience in a Quality Engineering role in a medical device manufacturing ·Experience in implementing and managing CAPA systems. ·Fluent in English and French
Skills: Quality Assurance, QMS, ISO 13485
I am looking for an experienced Quality assurance consultant to support a Medical device company for a 4 months project.
Starting date: August 2023
Responsibility:
- To establish and maintain procedures relative to quality documentation
- To provide support on quality system procedures
- To perform quality assurance review and facilitate the release of production batch
- To manage and monitor of CAPAs and non-conformities
- To participate in the audit, approval of suppliers, ensuring high-quality inputs for manufacturing process.
- To support in the Process Validation activities
- To support in preparing regulatory submissions in Europe and the USA.
Knowledge, Skills and Abilities:
- Bachelor’s or Master’s degree in Quality, Mechanical, Biomedical Engineering, or a related field
- Knowledge of quality systems, quality assurance techniques, and regulatory standards (e.g. ISO 13485 and FDA 21 CFR)
- Proficiency in the use of statistical analysis and quality improvement tools
- Proficiency in documenting all work reliably and accurately as per QMS standards
- Minimum 4 years of experience in a Quality Engineering role in a medical device manufacturing
- Experience in implementing and managing CAPA systems.
- Fluent in English and French
Oleksandra Moroz