Senior Quality Systems Engineer
Full time- Permanent
Galway- Hybrid
We have an exciting opportunity for a Senior Quality Systems Engineer to join Veryan Medical!
Summary
Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.
Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.
Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.
Reporting to the Quality Systems Manager, the Senior Quality Systems Engineer will play a key a key role in implementing and maintaining the Company’s Quality Management system. This is a fantastic opportunity, which will allow the successful candidate to work across a variety of activities as part of a supportive, collaborative team in our state-of-the-art facility here in Galway.
Job Requirements
Principal Responsibilities
- To ensure that Veryan 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 at Veryan.
- 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 Veryan 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.
Benefits of Working with Veryan:
- Competitive salary and bonus.
- Pension scheme with generous employer contributions.
- Private medical insurance for you, spouse / partner and dependents.
- Paid sick leave.
- Group life cover.
- Annual leave of 23 days plus bank holidays increasing with service.
- Active Sports and Social Committee with a schedule of events taking place during the year.
- Hybrid working.
- Flexible start and finish times.
- Opportunities for further education, training and development.
Company Values
- Collaborative
- Innovative
- Empowering
- Patient-centric
- Acting with Integrity
Please find information on the processing of your personal data in the Veryan Applicant Privacy Notice
