Our Client a medical device company in Galway are currently recruiting for a Quality Systems Engineer
The primary responsibility of this position is to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System processes. 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 entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Internal and External Audits, Quality Trending and Quality Management Review. Must interact with many different functional departments, suppliers, and experts outside the Company in order to communicate and implement company Quality Objectives
- Supports effective implementation of the Quality Management System (QMS) throughout the organization, including completing gap assessment and closure for any regulatory changes that have impact on the quality management system.
- Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the Companies process and applicable regulations/standards.
- Supports and manages site CAPA program including, collecting and analysing data to appropriately and efficiently identify ‘Root Cause’ and ensuring ‘Verification of Effectiveness’ plans are comprehensive, to facilitate overall improvement in performance of key quality system elements,
- Supports quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
- Supports site internal audit program, including conducting internal audits and ensuring that audits are completed on time and in full and that all observations are being addressed by owners as appropriate.
- Coordinates and supports effective management review process, ensuring all key quality performance trends are identified and dispositioned.
- Supports any 3rd party external audits and corporate audits through preparing the site; including supporting the front and back room.
Education, Experience and Skills
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, and measurement, analysis and improvement processes.
- Strong knowledge and understanding of 21 CFR 820, ISO 13485 and regulatory requirements applicable to the QMS.
- Qualified Auditor to 21 CFR 820 or ISO 13485/9001 (IRCA Accredited Lead Auditor qualification desirable).
- Demonstrated technical expertise
- Demonstrates ownership for the integrity of work
- Able to work independently and within a team, and consider options for completing work
- Ability to deliver, meet deadlines and have results orientation.
- Strong written and verbal communication skills, with ability to communicate to multiple levels of the company.
- Bachelor’s degree in Engineering, Technology or Science is required or an alternative Bachelor’s degree with certification as a Quality Engineer (e.g. CQE)
- Must be familiar with Microsoft Office Suite
- Must have minimum of 3 years of experience in Quality Engineering field
For further information on this Quality Systems Engineer role in Galway please contact Orla Crowley on 086 0449473/ email@example.com
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