I'm delighted to be working an excellent Quality Systems Engineer role with one of our exciting Medical Device clients in Galway. This is a full time role and offers strong salary and great benefits, along with hybrid working.
Job Requirements
Principal Responsibilities
* To ensure that Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 Japanese Ministerial Ordinance # 169 and other relevant regulations.
* Complete gap assessments & associated activities for QMS regulations.
* Coordinate the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure.
* To act as Coordinator for CAPA & Complaints processes. To maintain the CAPA and Complaint Systems, including review & approval of CAPA and Complaint investigation reports.
* Manage activities in the Software validation process.
* Maintain the electronic QMS in a validated state.
* To Manage Quality Systems data collection and analysis and to facilitate timely generation of Monthly Reports, Management Review data etc.
* Drive the timely and thorough completion of quality system actions by proactively monitoring due dates, identifying risks, and supporting cross-functional collaboration to implement effective mitigation strategies.
* Support the maintenance and continuous improvement of the quality management system processes.
* Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
* Act as Coordinator of the Temporary Authorisation process, coordinating Temporary Authorisation activities.
* Manage activities associated with Supplier Management Approval. This includes supplier selection, approval, monitoring and reporting.
* Provide Back-up support for Document Control (DCC) activities.
* Provide support for other Quality Systems activities, e.g. projects, supporting submissions.
Education & Training
* Educated at minimum to a Diploma Level in Engineering, Science or Quality Assurance discipline.
* Training/Qualification in Quality Systems, Risk Management, Complaint CAPA management, Auditing and Medical Device regulations is highly desirable.
Experience & Skills
* A minimum of five years’ relevent experience in the medical device or pharmaceutical industry is required.
* Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is desirable.
* Good communication and organisational skills, and the ability to present reports neatly and accurately is essential.
* Experience in management of Quality Systems activities, in particular Internal/ External Audit, Software Validation Complaints, Risk Management and CAPA is desirable.
#J-18808-Ljbffr