NPI Quality Engineer III

Mason Alexander New; Wexford; On-site; EUR 60,000 - 80,000; Full time

Job summary

Mason Alexander seeks an experienced NPI Quality Engineer to join the Design Assurance Team in Ireland. You will support product development from a quality perspective, working through PD phases, including test method development, IQ/OQ/PQ, DV testing and report writing.

As NPI Quality Engineer III, you will research and introduce new technologies and equipment, drive risk management per ISO14971, and lead continuous improvement projects for efficient NPI activities.

Qualifications

• Bachelor's degree in engineering or related field.
• At least 3 years in engineering within the medical device sector.
• Experience with R&D, product development or quality engineering.
• Experience with test method development and process validation is essential.
• Strong problem solving and communication skills.

Responsibilities

• Support New Product Introduction with design, tooling, testing and fixtures.
• Test and validate new methods; perform gage R&R and statistical analysis (Minitab).
• Support site quality activities: internal audits, readiness, CAPAs and QMS.
• Assist risk management per ISO14971 and participate in planning.
• Lead continuous improvement projects.
• Stay updated on new technologies and equipment to enhance NPI quality.

Skills

NPI quality engineering

Test method development

Process validation

Quality engineering

Project management

Communication skills

Minitab

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

Global Medical Device development & manufacturing company with a site in New Ross Wexford are seeking an experienced NPI Quality Engineer to join their Design Assurance Team on a permanent basis.

The role focuses on supporting various product development projects from a quality perspective. You would be working as part of a core team through the PD phases, including test method development, process validation (IQ,OQ,PQ), DV testing and report writing.

As the NPI Quality Engineer III, you would also research and introduce new innovative technologies and equipment.

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 through software packages such as Minitab.
• Support Site Quality Activities: support internal audits & readiness, CAPAs, QMS.
• Support planning execution of risk management activities per ISO14971.
• Lead continuous improvement projects.
• Remain up to date with latest technologies, tools and equipment relevant to NPI, testing, design assurance to improve efficiency of NPI quality activities.

Requirements:

• Bachelors Degree in an Engineering discipline or related degree maybe considered based on additional years of relevant experience.
• At least 3 years of experience in an engineering role in a medical device manufacturing company with focus on R&D, product development, process or quality engineering.
• Experience with test method development and process validation is critical to be considered for this role.
• Complex problem solving skills.
• Strong communication skills for internal & external stakeholder & project management.

Permanent role

Salary €60-80K (depending on experience)

On-site role