Quality Engineer (Hybrid) is required to ensure products meet quality and compliance standards by global medical technology client in Limerick.
The successful engineer will be involved in new product development and product sustaining projects through the application of Quality engineering skills. You will handle multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.
This is a great opportunity for am engineer who is passionate about quality standards and who is willing to play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements.
- Bachelor’s or Master’s Degree in an Engineering discipline.
- A minimum of 3 years of Quality Engineering experience.
- Great knowledge of regulatory standards such as, ISO 13485, QSR, ISO 14971, statistical techniques.
- Excellent written and verbal communication skills.
- Excellent organisational skills.
- Solid experience with MDR (Medical Device Regulations)
- Experience with IEC 62304 and IEC 62366 is an advantage.
- Lead as the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project.
- Ensure compliance across projects for design control, risk management, and change control processes.
- Write project quality plans and support the creation and maintenance of DHF documentation.
- Lead risk management activities within the project.
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
- Support the creation and implementation of verification and validation activities.
- Review and approve test protocol and reports.
- Review and challenge statistical rationale, and data analysis in the frame of test protocol and reports.
- Review and approve related execution deviations.
- Assist / conduct Failure investigations and problem-solving sessions.
- Conduct quality functional reviews and DHF (Design History File) compliance reviews.
MDR (Medical Device Regulation) specific needs:
- Ensure state of the art requirements are correctly applied.
- Ensure design controls standards are applied within the program (DDP/QP, Phase-gate etc.).
- Collaborate with stakeholders (in/out of MDR) to ensure appropriate MDR decisions are made.
- Create MDR compliant risk files ensuring file is up to date with state of the art standards.
- Support DHF evidence review as required.
- Support Quality culture within R&D organisation while providing training on applicable requirements / standards.
This role is Hybrid with occasional office presence in Limerick.
Our client offers an exciting work culture with opportunity for career growth as well as benefits such as: Pension, Health insurance, Death in Service Benefit, Sick pay scheme, Educational assistance, Annual Leave, etc.
Please send you CV in confidence to email@example.com