Quality Director (M/F)
other jobs Michael Page
Agregado antes 1023 Dias
- Madrid (Comunidad de)
- Unspecified
- Salario sin especificar
Job Description:
BSc degree in Medical Technology|Previous experience in the same position
Important industry-leading biotechnology company.
The QD in Madrid is responsible for the overall operation and administration of the company related to the quality policy and quality assurance procedures.
Management of Quality personnel within the Quality department.
Ensure the company health and insurance compliance by supervising and assisting the health and insurance personnel.
Keep up to date of current Quality Standards impacting the company procedures as FDA, CLIA, ISO15189, ISO13485, national licenses and other governing regulatory guidelines.
Control of the Quality Management Plan including preparation, revision, and execution.
Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
Management of Change Control and Document Control Systems.
Responsible, together with the Quality Manager, for preparation and revision of quality documentation and reports by collecting, analysing, and summarizing information and trends including failed processes, stability studies, corrective actions and re-validations.
The organization of quality and facilities inspections, preparation of procedures and instructions including certification assessment and surveillance audits, FDA/A2LA inspections, other regulatory inspections and supplier audits.
Perform, together with the Quality Manager, internal audits of laboratory tests and products that include pre-analytical, analytical and post analytical process in timely manner on set schedule each year.
Ensuring that validations are performed on equipment, processes and software used in the company procedures that require them.
Ensuring that processes needed for the quality management system are established, implemented, and maintained.
Ensuring the promotion of awareness of users’ needs and requirements throughout the laboratory organization.
Ensuring quality assessment and quality control programs are established and maintained.
Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly.
Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens.
Policies and procedures are established for monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing.
Review and approval of modified or updated documents and/or policies.
Good opportunity.
Important industry-leading biotechnology company.
The QD in Madrid is responsible for the overall operation and administration of the company related to the quality policy and quality assurance procedures.
Management of Quality personnel within the Quality department.
Ensure the company health and insurance compliance by supervising and assisting the health and insurance personnel.
Keep up to date of current Quality Standards impacting the company procedures as FDA, CLIA, ISO15189, ISO13485, national licenses and other governing regulatory guidelines.
Control of the Quality Management Plan including preparation, revision, and execution.
Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
Management of Change Control and Document Control Systems.
Responsible, together with the Quality Manager, for preparation and revision of quality documentation and reports by collecting, analysing, and summarizing information and trends including failed processes, stability studies, corrective actions and re-validations.
The organization of quality and facilities inspections, preparation of procedures and instructions including certification assessment and surveillance audits, FDA/A2LA inspections, other regulatory inspections and supplier audits.
Perform, together with the Quality Manager, internal audits of laboratory tests and products that include pre-analytical, analytical and post analytical process in timely manner on set schedule each year.
Ensuring that validations are performed on equipment, processes and software used in the company procedures that require them.
Ensuring that processes needed for the quality management system are established, implemented, and maintained.
Ensuring the promotion of awareness of users’ needs and requirements throughout the laboratory organization.
Ensuring quality assessment and quality control programs are established and maintained.
Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly.
Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens.
Policies and procedures are established for monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing.
Review and approval of modified or updated documents and/or policies.
Good opportunity.
Número de empleo 799760