informations générales
Bobigny
A French manufacturer of Class I medical devices for 30 years, LTA Médical, a GETINGE Group company, has developed a complete range of high-quality brushes and swabs, in reusable or single-use versions, for cleaning medical devices of all specialties. LTA Médical markets and develops innovative solutions for central sterilization.
LTA Médical also markets FAMOS medical equipment and devices, PEREG laboratory tests, Healthmark Industries medical devices and WIPAK, world leader in hospital sterilization packaging, among its partners.
We are looking for a QHSE Manager M/F :
Responsibilities :
Quality assurance
- Represent local management with regard to the quality management system. Act as representative of local management and PRRC.
- Represent local management in external audits and inspections.
- Develop, define, maintain and revise Quality Management System processes and procedures to ensure company and product compliance with applicable regulations and laws.
- Develop and control quality objectives for quality assurance and quality management activities.
- Measure and monitor the performance of quality management system processes, analyze quality performance measures and report to management.
- Ensure that effective document and record control processes are developed and maintained.
- Organize and prepare management review meetings and report on Quality Management System performance to local senior management.
- Prepare audit schedules, execute internal audits and evaluate audit reports.
- Ensure that an independent product release process is in place.
- Identify and follow up on CAPAs.
- Manage the day-to-day operations of the Quality Assurance function to achieve quality objectives.
- Ensure that supplier controls are sufficient.
- Ensure that necessary validations are performed on equipment, processes and software used in manufacturing and product testing.
Compliance
- Ensure that the production site has implemented a quality system fully compliant with ISO 9001, ISO 13485, EU MDR 2017/745 and any other applicable regulations, and have knowledge of ISO 14001 and ISO 45001.
- Ensure that the quality policy and quality manual (site quality plan) are implemented and communicated to all levels of the organization.
- Ensure quality plans are implemented to minimize compliance and business risks.
Leadership
- Interface with the entire organization (manufacturing operations, engineering, supplier quality, etc.) regarding the identification and resolution of quality issues.
- Lead the team to achieve company goals and objectives.
- Select, develop, lead and manage the performance of quality personnel.
Skills:
- At least 5 years' experience in quality assurance in a medical device manufacturing environment.
- Previous training and experience in quality assurance and manufacturing
- Strong knowledge and experience of ISO 9001, ISO 13485, EU MDR 2017/745 and other related regulatory requirements, as well as ISO 14001 and ISO 45001.
- Successful interactions and experience with regulatory agencies
- Good knowledge of statistics and practical application of ISO 9001, ISO 13485, ISO 14001 and ISO 45001.
En savoir plus sur cette annonce sur le site de notre partenaireLTA Médical also markets FAMOS medical equipment and devices, PEREG laboratory tests, Healthmark Industries medical devices and WIPAK, world leader in hospital sterilization packaging, among its partners.
We are looking for a QHSE Manager M/F :
Responsibilities :
Quality assurance
- Represent local management with regard to the quality management system. Act as representative of local management and PRRC.
- Represent local management in external audits and inspections.
- Develop, define, maintain and revise Quality Management System processes and procedures to ensure company and product compliance with applicable regulations and laws.
- Develop and control quality objectives for quality assurance and quality management activities.
- Measure and monitor the performance of quality management system processes, analyze quality performance measures and report to management.
- Ensure that effective document and record control processes are developed and maintained.
- Organize and prepare management review meetings and report on Quality Management System performance to local senior management.
- Prepare audit schedules, execute internal audits and evaluate audit reports.
- Ensure that an independent product release process is in place.
- Identify and follow up on CAPAs.
- Manage the day-to-day operations of the Quality Assurance function to achieve quality objectives.
- Ensure that supplier controls are sufficient.
- Ensure that necessary validations are performed on equipment, processes and software used in manufacturing and product testing.
Compliance
- Ensure that the production site has implemented a quality system fully compliant with ISO 9001, ISO 13485, EU MDR 2017/745 and any other applicable regulations, and have knowledge of ISO 14001 and ISO 45001.
- Ensure that the quality policy and quality manual (site quality plan) are implemented and communicated to all levels of the organization.
- Ensure quality plans are implemented to minimize compliance and business risks.
Leadership
- Interface with the entire organization (manufacturing operations, engineering, supplier quality, etc.) regarding the identification and resolution of quality issues.
- Lead the team to achieve company goals and objectives.
- Select, develop, lead and manage the performance of quality personnel.
Skills:
- At least 5 years' experience in quality assurance in a medical device manufacturing environment.
- Previous training and experience in quality assurance and manufacturing
- Strong knowledge and experience of ISO 9001, ISO 13485, EU MDR 2017/745 and other related regulatory requirements, as well as ISO 14001 and ISO 45001.
- Successful interactions and experience with regulatory agencies
- Good knowledge of statistics and practical application of ISO 9001, ISO 13485, ISO 14001 and ISO 45001.
