NPI Quality Engineer: Drive New Product Excellence

Integer

Galway

On-site

EUR 45,000 - 75,000

Full time

10 days ago

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Job summary

Integer in Galway is seeking a New Product Design & Development Quality Engineer to provide quality leadership, direction and technical guidance across QA, QC and preventive activities, with a focus on continuous improvement of products and processes. You will lead initiatives to enhance quality performance and support internal customers on quality issues.

You will mentor engineers, collaborate with cross-functional teams, ensure compliance to ISO 13485 and regulatory standards, and drive risk

Qualifications

Bachelor's degree in Engineering or Science with 1–3 years of experience.
Working knowledge of ISO 13485:2016 and medical device manufacturing.
Experience with NPI and process validation.
Strong problem-solving and analytical skills.
Ability to collaborate across cross-functional teams.

Responsibilities

Provide quality leadership and technical guidance in QA, QC and preventive activities.
Lead initiatives to improve product and process quality.
Support NPIs, design transfer and product releases.
Develop and review test strategies, reports and VV documentation.
Contribute to risk assessments and lifecycle change management.
Mentor engineers and collaborate with project teams to ensure on-time launches.