Position Summary
The Quality Manager will have overall responsibility for the Quality function, including management of the current Quality Management System.

Responsibilities

• The Quality Manager is responsible for:
• • Ensuring that the processes needed for the Quality Management Systems are clearly documented, effectively communicated, and maintained in accordance with the governing Quality Standards and applicable Regulatory requirements and understood by all employees.
• The Quality Manager is also designated as the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of MDR 2017/745 and assumes responsibility for ensuring the following:
• • • Design Release: Device Design conformity is appropriately checked in compliance with the Quality Management System and governing regulatory standards under which the devices are manufactured before a device is released.
• • • The Technical Documentation is accurate and current at all times.
• • • The EU Declaration of Conformity is complete and current when applicable.
• Reporting to Top Management on the effectiveness of the quality management system and opportunities for improvement
• Management of the Quality System to ensure its ongoing compliance to the governing Quality and Regulatory Standards and its effectiveness in designing and developing sterile medical devices.
• Management of the Quality System audit program both internally and external audits of critical subcontractors and crucial suppliers.
• Management of the Supplier Agreement program with critical subcontractors and crucial suppliers
• Execute and/or support the Sterilization validation (including clinical cycles) of the FASTWIRE System in compliance with current revisions of SIO 11135 and ISO 10991-7 is desirable.
• Management of all Biocompatibility activities in conjunction with an approved Supplier to ensure compliance with current revisions of ISO 10993 series and FDA guidelines.
• Review and disposition of sterile clinical lots and intended commercial lots in compliance with the QMS
• Manage/support all regulatory Inspections acting in the capacity of primary contact representative.
• Represent company professionally and positively externally to Agencies, Regulators and Suppliers.
• Management of the Quality team to ensure the timely completion of all deliverables.

Knowledge and skills required

• Minimum education of degree in engineering or another relevant scientific discipline.
• Minimum 6 years' experience in the medical device industry, with at least four years of professional experience in Quality Management role within Medical Devices.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
• Sterilization and Microbiology experience in a medical device company desirable.
• External agency inspection experience
• Accuracy of information essential
• Ability to work well under deadlines and pressure
• Good business acumen.

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