Quality Systems Engineer
Salary/Rate:€40,000 - €50,000 DOE
Job type:Perm
Town/City:Paris
Country:France
Business Sectors:Quality
Job ref:24494
Post Date:06. 09. 2023
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About the Role
Quality Systems Engineer
Location: Paris, France
Salary: €40,000 - €50,000 DOE
Overview:
Our global client produces Medical Devices to address the need of monitoring the patient's vital signs. At their location In Paris, they develop, manufacture, and distribute Cables, lead wires and electrodes to the global market.
They are currently looking for a Quality Systems Engineer to strengthen the Quality team in France. Under the leadership of the site Quality Manager and in a team of 8 people, this role will be responsible for the application, maintenance, and continuous improvement of the quality management system (QMS). The Quality Systems Engineer will ensure processes are implemented effectively, and serve the business, as well as meeting regulatory requirements.
Benefits:
• Generous paid time off, including vacation, holidays, and personal days.
• Good career progression opportunities
• Competitive salary
• Warm, welcoming, and respectful working environment
• Supportive and approachable management team
• Modern and well-equipped workspaces
• Opportunity to contribute to meaningful and impactful projects.
• Emphasis on work-life balance and employee well-being
Tasks:
• Supports the establishment and maintenance of the quality system documentation by ensuring compliance with EU MDR, FDA 21 CFR 820, ISO 13485, and other regulatory requirements.
• Performs internal audits to assess compliance to Standards and to the internal Quality System, including investigation, presentation of observations and findings, and reporting.
• Escalates areas of non-compliance, risk, and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies.
• Proactively identifies improvement opportunities in all business functions and develops tools that allow for visibility into process bottlenecks and inconsistencies.
• Utilizes the corrective and preventive action process to correct compliance non-conformances and drive improvement of the QMS.
• Performs periodic trend analysis of various quality system elements to identify opportunities for improvement and provide inputs to Management Review.
• Reports to the Quality Manager on the effectiveness of the QMS, including the need for any improvements.
• Support internal audits, supplier audits, and external audits.
• Develops, improves, revises and maintains procedures and work instructions as needed by the organization.
• Assists in the drafting or execution of qualification/ validation documentation as required by the QMS.
• Provides support to Quality Manager as appropriate.
• Performs other duties as assigned.
Your Profile:
• Bachelor’s degree in quality management or equivalent experience
• Ideally 5+ years of experience in quality department
• Robust knowledge of EU MDR, 21 CFR 820 and ISO 13485 at a minimum
• Strong technical writing skills, organization, and attention to detail
• Internal and external auditing experience
• Professional English
• Ability to communicate effectively with management, technical teams, and all organizations in the business
• Experience with quality tools including root cause and corrective action, QMS, and process auditing, and statistical analysis of quality metrics
• Ability to take initiative and work independently to complete tasks in an accurate and timely manner
• Strong problem-solving skills
• Ability to work independently, self-driven
For more information or to apply please contact Luke Fines with your CV at luke.fines@adaptivelifescience.com
#LI-LF1
Location: Paris, France
Salary: €40,000 - €50,000 DOE
Overview:
Our global client produces Medical Devices to address the need of monitoring the patient's vital signs. At their location In Paris, they develop, manufacture, and distribute Cables, lead wires and electrodes to the global market.
They are currently looking for a Quality Systems Engineer to strengthen the Quality team in France. Under the leadership of the site Quality Manager and in a team of 8 people, this role will be responsible for the application, maintenance, and continuous improvement of the quality management system (QMS). The Quality Systems Engineer will ensure processes are implemented effectively, and serve the business, as well as meeting regulatory requirements.
Benefits:
• Generous paid time off, including vacation, holidays, and personal days.
• Good career progression opportunities
• Competitive salary
• Warm, welcoming, and respectful working environment
• Supportive and approachable management team
• Modern and well-equipped workspaces
• Opportunity to contribute to meaningful and impactful projects.
• Emphasis on work-life balance and employee well-being
Tasks:
• Supports the establishment and maintenance of the quality system documentation by ensuring compliance with EU MDR, FDA 21 CFR 820, ISO 13485, and other regulatory requirements.
• Performs internal audits to assess compliance to Standards and to the internal Quality System, including investigation, presentation of observations and findings, and reporting.
• Escalates areas of non-compliance, risk, and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies.
• Proactively identifies improvement opportunities in all business functions and develops tools that allow for visibility into process bottlenecks and inconsistencies.
• Utilizes the corrective and preventive action process to correct compliance non-conformances and drive improvement of the QMS.
• Performs periodic trend analysis of various quality system elements to identify opportunities for improvement and provide inputs to Management Review.
• Reports to the Quality Manager on the effectiveness of the QMS, including the need for any improvements.
• Support internal audits, supplier audits, and external audits.
• Develops, improves, revises and maintains procedures and work instructions as needed by the organization.
• Assists in the drafting or execution of qualification/ validation documentation as required by the QMS.
• Provides support to Quality Manager as appropriate.
• Performs other duties as assigned.
Your Profile:
• Bachelor’s degree in quality management or equivalent experience
• Ideally 5+ years of experience in quality department
• Robust knowledge of EU MDR, 21 CFR 820 and ISO 13485 at a minimum
• Strong technical writing skills, organization, and attention to detail
• Internal and external auditing experience
• Professional English
• Ability to communicate effectively with management, technical teams, and all organizations in the business
• Experience with quality tools including root cause and corrective action, QMS, and process auditing, and statistical analysis of quality metrics
• Ability to take initiative and work independently to complete tasks in an accurate and timely manner
• Strong problem-solving skills
• Ability to work independently, self-driven
For more information or to apply please contact Luke Fines with your CV at luke.fines@adaptivelifescience.com
#LI-LF1