Senior Design Quality Engineer
We will also consider not Senior candidates for this role
Location: Galway - Hybrid working - 3 days a week on site
Duration: Until December 2025
Hours: 39 per week
To provide Design Quality technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Ensure compliance with applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents. Provide design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements, and complaint investigations.
Roles and Responsibilities
1. Ensure Design control and Risk Management activities comply with the requirements of the Design Control and Risk Management processes.
2. Support new product development and lifecycle management activities within the Design Quality team.
3. Provide leadership in understanding medical device regulations, specifically compliance to Design Control Regulatory requirements in global markets.
4. Guide product development teams on effective application of design controls and risk management.
5. Collaborate with design teams on identifying design input, establishing design outputs, failure mode prevention, test method development, validation, and design transfer and launch planning.
6. Identify critical to quality requirements and translate them into design and processing specifications.
7. Develop risk management processes with risk control measures to ensure device safety and performance, driving continuous improvement.
8. Manage and complete Quality deliverables for R&D projects.
9. Provide Quality support and guidance to R&D project leads and team members.
10. Supervise and coordinate Design Quality Engineers and Quality Engineers as needed.
11. Coordinate resources to support business objectives.
12. Engage with partners to resolve issues promptly and drive consensus.
13. Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
14. Maintain records related to design control projects.
15. Participate in design review meetings.
16. Review and approve R&D batches, sterilization records, and production records to meet cycle validation and product requirements.
17. Support bench testing activities as required.
18. Monitor data from Quality Management systems and provide feedback on deviations or issues.
19. Lead or facilitate compliance and improvement activities related to the Quality System (e.g., CAPA/non-conformance).
20. Prepare data for management review.
21. Act as an audit escort and support inspection activities as needed.
22. Support internal and supplier audits.
23. Support regulatory activities for projects and lifecycle management.
24. Conduct Quality System training for employees as directed.
25. Represent Johnson & Johnson MedTech Neurovascular professionally to external agencies, vendors, and regulators.
26. Communicate business issues or opportunities to management.
27. Collaborate with Regulatory Affairs on regulatory submissions.
28. Support post-launch activities such as complaints and CAPA management.
29. Communicate effectively across departments and levels.
30. If supervising staff, ensure compliance with health, safety, and environmental guidelines and proper resource management.
31. Ensure compliance with all relevant regulations, policies, and procedures.
How to Succeed
We will also consider less Senior candidates for this role
* Degree in a technical field preferred.
* At least 5 years’ experience in the medical device or related industry, with 3+ years in a role responsible for QMS processes.
* Knowledge of design control, risk management, sterilization, and Quality Assurance principles.
* Experience with external agency inspections (e.g., FDA, Notified Bodies).
* Strong teamwork, communication, and project management skills.
* Thorough knowledge of Design Control, Risk Management, 21 CFR 820, ISO 13485, and other relevant standards.
* Ability to handle multiple projects under deadlines and pressure.
* Excellent communication skills, both verbal and written.
Benefits
This role offers a competitive hourly rate. Contract until December 2025.
You are welcome here
Johnson & Johnson fosters an inclusive environment where diverse backgrounds and perspectives are valued, ensuring everyone feels they belong and can reach their potential.
About Cerenovus
Cerenovus, part of Johnson & Johnson MedTech, is a leader in neurovascular care, dedicated to improving stroke treatment and patient outcomes. Join us to contribute to healthcare breakthroughs.
Application Process
We aim to process applications within 2 working days. Applications via email are not accepted. Pay rate depends on payment method (PAYE, LTD, Umbrella).
Diversity, Equity & Inclusion
Our commitment to DEI is embedded in our culture, reflecting our values and business practices. We believe diverse teams drive innovation and success, and everyone should feel they belong and can thrive at Johnson & Johnson.
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