Job Summary:

Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISOI 3485:2016, MDSAP and FDA requirements. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.

Job Responsibilities/Duties:

• Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
• Lead preparation and coordination activities for external audits and liaise as required with SME’s to ensure audits are conducted in an efficient manner.
• Co-ordinate the Document Control Function in conjunction with the appropriate resources.
• Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
• Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAP As are completed in a thorough and timely manner.
• Assist with Management review planning and execution.
• Promotes the awareness of regulatory and customer requirements throughout the organization.
• Supports Quality training on site.
• Methodical review approach and be capable of initiating and leading change and continuous improvement.
• Other project work as assigned by the Quality Systems Manager.

Education/Experience:

• A degree in Engineering, Technology, or Science.
• At least 3-5 years’ experience working in a regulated medical device or pharmaceutical company.
• Excellent verbal and written communication skills.
• Excellent planning and coordination skills.
• Excellent attention to detail skills

Specific Requirements::

• Ability to work within a team environment to achieve agreed company goals.
• Ability to communicate quality / regulatory concepts effectively.
• Excellent understanding of EN ISO 13485:2016, MDSAP ad FDA regulations.
• Formal Audit Training.
• Proficiency in use of desktop software applications such as MS office.
• Some travel may be required with the role.