ESSENTIAL JOB FUNCTIONS:
- Maintain the quality system in compliance with Annex V, Annex VII and Article 11 of the Medical Device Directive 93/42/EEC, and relevant EMEAA regulations.
- Ensure that satisfactory standards of quality, sterility, and biological safety are maintained and ensure the Quality System at all times meets ISO 13485 and any other standards which may apply from time to time.
- Act as Quality System Management representative as outlined in ISO 13485 and any other applicable Quality Management Standard.
- Ensure Class I and Class IIa products meet all the relevant provisions of the Medical Device Directive 93/42/EEC in relation to CE marking.
- Ensure that all specifications, processes, materials and products are appropriate for their intent and purpose and in compliance with approved, agreed requirements.
- Ensure all sampling plans and test methods and procedures are appropriate for their intent and purpose.
- Ensure that Customers requirements are understood and that all responses to Customers are in a timely manner, are accurate and meet / exceed the customers needs.
- Identify and prioritise policies and objectives necessary to achieve and maintain quality standards as committed to in the quality policy.
- Ensure contributions are actively encouraged from quality department for cost improvement and continuous improvement and ensuring all projects and reports are completed in an accurate and timely manner.
- Inform the Notified Body of any significant changes in systems or procedures which could potentially affect registration.
- Communicate with the relevant Competant Authorities and Notified Body regarding vigilance Ensure all vigilance activities, including FSCA, are performed in a timely and efficient manner.
- Ensure all Non conforming events are investigated, the root cause identified and if necessary escalated to the Corrective and Preventive Action (CAPA) system. Ensure that the CAPA system works effectively.
- Ensure all resources of personnel and equipment allocated to the quality department are utilized efficiently.
- Promote and maintain safety, health and welfare in accordance with regulatory and company policies and procedures.
- Lead, motivate and develop the quality team in line with company policy and HR strategy including recruitment, training and performance management.
- Communicate effectively and work with teammates and customers from diverse backgrounds and cultures.
- Prepare and present annual budget for the department and manage activities within the limitations of the approved budget.
- Support a culture of Continuous Improvement and carry out projects and duties as assigned to you in an efficient, timely and cost effective manner.
- To approve or reject, as seen fit, starting materials, packaging materials, and intermediate, bulk and finished products
- To ensure that the appropriate validations are done.
- To ensure that the required initial and continuing training of the quality department personnel is carried out and adapted according to need.
- The monitoring and control of the manufacturing environment.
- The approval and monitoring of suppliers of materials.
- The approval and monitoring of contract manufacturers.
- The monitoring of compliance with the requirements of GMP.
EDUCATION & EXPERIENCE REQUIRED:
- Educated to degree or equivalent level in an Engineering or Scientific Discipline.
- 3/5 years Quality Assurance, or Microbiology in the Medical Device or Pharmaceutical field.
- Experience with sterilization systems and validation.
KNOWLEDGE SKILLS & ABILITIES:
- Be customer focused in an ever changing dynamic marketplace.
- Ability to analyse information, draw conclusions and make sound and timely decisions.
- Ability to deal with ambiguity, rapidly prioritise and respond to change quickly.
- A passion for continually improving processes with a focus on results.
- Financially astute and bottom line driven with a good aptitude for numbers.
- Demonstrated people management skill, a strong team builder with good strategic perspective who possesses strong influencing and communication skills
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists