Liaise with company wide departments to ensure internal system compliance and customer specifications are achieved.
Ensure the timely and effective closure of internal/external quality issues.
Coach and drive a culture of compliance and continuous improvement.

• Must have a third level qualification in Engineering/Quality/Science.
• Must have work experience in a Medical Device design and manufacturing environment.
• Must have an in-depth knowledge of design and development processes and risk management planning.
• Experience and in-depth knowledge of validations in a Medical Device environment.
• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• Ideally would have experience of FDA audits and the preparation of same.
• Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
• Must have excellent communication skills both oral and written.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.

• Must have five+ years working experience in a quality environment in either the Medical Device / Pharmaceutical Industry. Ideally have Medical Device and Drug Handling Experience.
• A thorough working knowledge of quality systems such as ISO 9001:2000 and ISO 13485 is considered essential. Additional knowledge of 21 Part 820 and/ or 21 Part 211 would be considered an advantage.
• Thorough understanding of statistics, SPC, and the use of Minitab.
• Must have working knowledge of validation activities. participate in internal validations document review and approval to ensure quality requirements are adhered to, this will include the writing of Validation Master Plans, the reviewing of validation protocols and reports to ensure quality compliance.
• Must have experience of design and development systems against international requirements.
• Knowledge of CE marking would be advantages
• Risk Management experience in a design & development is a requirement with good working knowledge of ISO14971
• Auditing experience to the requirements of ISO 9001:2000, ISO 13485 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.
• Co-ordinate activities associated with change management and customer interaction.
• Review of quality document to drive compliance ie batch reports, metrology reports etc..
• Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective actions are closed in a timely manner.
• Management of customer documents into the TGE Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
• Must be able to work in a team environment.
• Must be able to prioritize and organise tasks.
• Must have excellent communication skills both oral and written.