NPI Quality Engineer - Medical Device R&D & Validation

Mason Alexander; Wexford; On-site; EUR 65,000 - 85,000; Full time

Job summary

Mason Alexander is seeking an experienced NPI Quality Engineer III for a permanent role at a global medical device site in New Ross, Wexford. The role focuses on supporting product development from a quality perspective and contributing to design assurance throughout the PD phases.

You will engage in test method development, process validation (IQ, OQ, PQ), DV testing and report writing, while researching and introducing new technologies and equipment to enhance NPI quality activities.

Qualifications

• Bachelor's degree in an engineering discipline is required or may be considered with additional relevant experience.
• At least 3 years in an engineering role in a medical device company (R&D, product development, process or quality).
• Experience with test method development and process validation is essential.
• Candidates should have strong problem-solving abilities and good communication skills for internal/external stakeholders and project management.

Responsibilities

• New Product Introduction Support: apply engineering concepts for complex problem solving, design & carry out new tooling, testing, fixtures and templates.
• Carry out testing and validation of new test methods including gage R&R studies and statistical analysis of data using software like Minitab.
• Support Site Quality Activities: assist internal audits, readiness, CAPAs and QMS.
• Support planning and execution of risk management activities per ISO14971.
• Stay updated with latest technologies and equipment relevant to NPI, testing and design assurance to improve efficiency of NPI quality activities.

Skills

Complex problem solving

Strong communication

Project management

Education

Bachelor's degree in engineering

Tools

Minitab

Gage R&R

Job description

Mason Alexander is seeking an experienced NPI Quality Engineer III for a permanent role at a global medical device site in New Ross, Wexford. The role focuses on supporting product development from a quality perspective and contributing to design assurance throughout the PD phases.

You will engage in test method development, process validation (IQ, OQ, PQ), DV testing and report writing, while researching and introducing new technologies and equipment to enhance NPI quality activities.