Senior Design Quality Engineer
Location: Cerenovus, Galway
Working mode: Hybrid, 3 days on-site and 2 WFH
Duration: 12 months
Hours: Full-time, 40 hours per week
Pay rate range: Competitive hourly rate
Imagine your next project as Senior Design Quality Engineer at Cerenovus, Galway. This role's purpose is to provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents.
Roles and Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
1. Responsible for ensuring Cerenovus Design control and Risk Management activities comply with the requirements of the Cerenovus Design Control and Risk Management processes.
2. Provide Quality support/guidance to R&D project leads/team members.
3. Provide direction and support to Design Assurance engineers and Quality Engineers.
4. Coordinate the Design Assurance Engineer resources to support Cerenovus business objectives.
5. Resolve project issues by working with team members, suppliers, and others as appropriate.
6. Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
7. Manage and maintain records related to design control projects.
8. Contribute and participate in design review meetings.
9. Provide input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA, and associated reports.
10. Provide input into the development of protocols/reports supporting the Design control process.
11. Coordinate timely review and approval of all details in R&D batch sterilization records.
12. Support bench test activity as required.
13. Support the translation of the design requirements into manufacturing requirements.
14. Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
15. Administration and management of the Cerenovus systems for CAPA, non-conformances, and supplier corrective actions.
16. Preparation of data for use in management review.
17. Act as an audit escort and/or support coordination of backroom activity during inspections as required.
18. Compile and conduct Quality System training for employees as directed.
19. Responsible for communicating business-related issues or opportunities to the next management level.
Minimum Requirements
Minimum education of degree in a technical field is preferred. Minimum 5 years experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes. Demonstrated knowledge of the application of the principles, concepts, and practices of design control, sterilization, and Quality Assurance processes. Ability to handle multiple projects simultaneously and to discern major quality issues.
Benefits
This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension.
You are welcome here
Cerenovus is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued.
Application Process
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson.
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