Senior Quality Systems Engineer

Permanent position with a growing Medical Device company for a Quality Systems Engineer in Galway Business Park.

Job Summary:

Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485:2016, 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

Benefits:

Career progression, excellent salary, pension, healthcare and yearly bonus.

Responsibilities:
. 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 complaints system to ensure that all complaints are completed in a thorough and timely manner.
. Co-ordinate quality system review activities and reporting.
. Promotes the awareness of regulatory and customer requirements throughout the organization.

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 planning and coordination skills.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales