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Quality Systems Engineer

Real Staffing Group

Posted on Nov 10, 2020 by Real Staffing Group

Galway, Ireland
Immediate Start
Annual Salary

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


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, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales.

Reference: 1001079127

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