Join a team dedicated to delivering high-quality products and services.
Job Description
The Quality Assurance Manager is responsible for leading the implementation and maintenance of our Quality Management System (QMS). This individual will provide quality support across manufacturing, supply chain, and design assurance functions. They will act as a cross-functional representative of the Quality team, driving collaboration and alignment across departments.
Key Responsibilities:
* Drive the day-to-day implementation of the QMS.
* Ensure delivery of overall quality strategy & support achievement of business quality objectives.
* Collaborate with wider team to ensure necessary QA activities are planned, executed and documented.
* Interpret relevant standards and ensure compliance with requirements.
* Develop and review test specifications, part specifications & design specifications with cross-functional team.
* Support manufacturing team activities associated with manufacturing in a regulated environment.
* Provide practical QA and Design Assurance expertise.
* Support supply chain in supplier-related activities.
* Coordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint process.
Required Skills and Qualifications
To be successful in this role, you will need:
* Bachelor's Degree in Engineering, Science or related field.
* 3+ years' experience in medical device quality/design assurance role.
* Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards.
Benefits
This role offers:
* Competitive health insurance plan.
* Pension 8% employer contribution.
* Employee share ownership programme.
* Discretionary bonus plan.
* Discounted gym membership at DCU & UCD gyms.
* Taxsaver Commuter Tickets & Bike to Work Scheme.
* EAP (Employee Assistance Programme).
* Employer-funded Sports & Social Committee.
Qualification & Experience
Our ideal candidate will have:
* Master's degree in Engineering, Science or related field.
* Experience in implantable medical devices.
* Experience with process development and change management in regulated environment.
This role reports to the Quality Systems Manager.