Quality Assurance Engineer H/F-00000KX8
Description
We are looking for a Quality Assurance Coordinator H/F for our site based in Illkirch (near Strasbourg - 67).
Mission
- Manage, improvs existing quality system (document review, audit plan, quality plan, quality manual) and contribute to the deployment of quality culture and continuous improvement in alignment with EMEA and OCD Franchise/MDD strategies.
- Guarantee compliance with regulatory requirements (IVD Directive, ISO13485/9001, GMPs, GDPs) and company’s SOP’s
- Drive Quality System Management Review
- Coordinate the implementation and monthly update of the dashboard.
- Participate to the management of all the Distribution Regulatory matters (IVDD, ISO...)
- Apply and supervise cGMPs and GDPs
- Monitor Quality Deviations, Non conformances and defines corrective/preventive actions
- Coordinate the update and maintenance of all procedures in collaboration with other departments.
- Provide high quality support to affiliates in the countries, Supply Chain, Customer services, SRMS, MDD SQA, and Franchise QRC informing them on all-important Q.R.C matters.
- Drive quality improvements where possible in line with customer expectations and in collaboration with other departments (Supply Chain, EMEA Quality, Customer Service etc.)
- Drive Customer satisfaction survey
- Provide QRC management of assigned LOB (Stop Shipments, In Bond/De Bond, inspection, rework, repack/re-labelling, NC product handling, product distribution control, product release, batch review, validation, change control, risk assesment etc.)
- Lead/Participate in the internal or/and external audits/assessments, regulatory agencies inspections.
Qualifications
- Five years after bachelor degree Bac +5, engineer, master or equivalent
- Specialized in Quality Management
- First experience of 5 years in industry if possible Medical Device, pharmaceutical, Biotechnology sector (food or chemical industry sector possible but as backup solution)
- Fluent in English.
- At ease in an International environment.
- Able to manage multiple tasks with prioritization
- Manage stressful situation
- Results oriented
- Well organised.
- Strong attention to detail.
- Excellent interpersonal and communication skills.
- High degree of autonomy.
- Computer skills, PowerPoint, Excel, Word, Internet.
- Two or three years of quality experience would be an advantage
- Good understanding of ISO 9001:2008
- Good understanding of cGMPs, GDPs
- Knowledge of ISO13485 and ISO14971 is a PLUS
Primary Location:Europe/Middle East/Africa-France-Alsace-Bas-Rhin
Organization: Ortho Clinical Diagnost (8215)
Job Function: Quality Assurance
Description
We are looking for a Quality Assurance Coordinator H/F for our site based in Illkirch (near Strasbourg - 67).
Mission
- Manage, improvs existing quality system (document review, audit plan, quality plan, quality manual) and contribute to the deployment of quality culture and continuous improvement in alignment with EMEA and OCD Franchise/MDD strategies.
- Guarantee compliance with regulatory requirements (IVD Directive, ISO13485/9001, GMPs, GDPs) and company’s SOP’s
- Drive Quality System Management Review
- Coordinate the implementation and monthly update of the dashboard.
- Participate to the management of all the Distribution Regulatory matters (IVDD, ISO...)
- Apply and supervise cGMPs and GDPs
- Monitor Quality Deviations, Non conformances and defines corrective/preventive actions
- Coordinate the update and maintenance of all procedures in collaboration with other departments.
- Provide high quality support to affiliates in the countries, Supply Chain, Customer services, SRMS, MDD SQA, and Franchise QRC informing them on all-important Q.R.C matters.
- Drive quality improvements where possible in line with customer expectations and in collaboration with other departments (Supply Chain, EMEA Quality, Customer Service etc.)
- Drive Customer satisfaction survey
- Provide QRC management of assigned LOB (Stop Shipments, In Bond/De Bond, inspection, rework, repack/re-labelling, NC product handling, product distribution control, product release, batch review, validation, change control, risk assesment etc.)
- Lead/Participate in the internal or/and external audits/assessments, regulatory agencies inspections.
Qualifications
- Five years after bachelor degree Bac +5, engineer, master or equivalent
- Specialized in Quality Management
- First experience of 5 years in industry if possible Medical Device, pharmaceutical, Biotechnology sector (food or chemical industry sector possible but as backup solution)
- Fluent in English.
- At ease in an International environment.
- Able to manage multiple tasks with prioritization
- Manage stressful situation
- Results oriented
- Well organised.
- Strong attention to detail.
- Excellent interpersonal and communication skills.
- High degree of autonomy.
- Computer skills, PowerPoint, Excel, Word, Internet.
- Two or three years of quality experience would be an advantage
- Good understanding of ISO 9001:2008
- Good understanding of cGMPs, GDPs
- Knowledge of ISO13485 and ISO14971 is a PLUS
Primary Location:Europe/Middle East/Africa-France-Alsace-Bas-Rhin
Organization: Ortho Clinical Diagnost (8215)
Job Function: Quality Assurance
