Industry : Medical Device
The Quality Engineer is a member of the Quality Systems department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. The Quality Engineer supports Business Unit’s Quality Management System (QMS) integration activity across the site to ensure ongoing compliance and continuous improvement. The position reports to the Quality Systems & Compliance Manager.
The Quality Engineer works on Complaint activities that support and guide in discharging their regulatory obligations to conduct Complaint Handling, Vigilance Reporting and Post Market Surveillance activities.
Role Responsibilities and Duties:
Support Global Business Unit (BU) in executing the Complaint Handling process, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines.
Proactively assist the BU and manufacturing sites to investigate and address complaints, to allow them to reduce/ eliminate predictable and repeating complaint types occurring in the future.
Ensure all complaints are investigated effectively and efficiently to meet required timelines and are fully compliant with our procedures and documented in our complaints management system.
Work collaboratively with teams across the BU to resolve customer complaints and serve as point of contact for complaints.
Assess product complaints and determine if escalation is required due to potential regulatory notification requirements. Subject Matter Expert (SME) for the product complaints during Internal, External and Regulatory Body inspections.
Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the Galway Legal Manufacturer (LM).
Possesses and applies a broad and increasing knowledge of Quality, and its application within the Business Unit.
Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
Develops effective quality metrics and communicates results to key stakeholders. Assists in the preparation and maintenance of records associated with the management review process.
Applies problem-solving skills to deal creatively with moderately complex situations.
Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
Update and create quality procedures as required through the change control process.
Participate in and support internal and external audits across the BU.
Implement the CAPA system ensuring that comprehensive root cause analysis is completed and that corrective and preventative actions are implemented.
Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.
Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Able to travel internationally (approximately 10% annually).
Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).
Experience with CAPA investigation management systems.
Role Education & Experience:
Third level qualification in Science/ Engineering.
Minimum 5 years of experience in medical device industry with minimum 3 years of progressively responsible positions.
Audit experience would be an advantage.
Duration: 12-month contract