Quality Engineer II

Freudenberg Group
An Spidéal, Connacht, Ireland
Full Time
On Site
Senior
0+
Bachelor Degree
Engineering Healthcare Life Sciences

Posted 2 months ago

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Excellent 4.7

Job summary

This role involves ensuring compliance with quality standards and regulations in medical device manufacturing, conducting audits, managing quality assurance processes, leading investigations into quality issues, and supervising staff, with a focus on continuous improvement and regulatory adherence.

Responsibilities

The Quality Engineer II will ensure manufacturing processes and quality systems comply with regulatory and customer requirements while managing quality issues and CAPA investigations. They will also supervise assigned staff, conduct supplier audits, and lead validation activities to ensure product quality and safety.

Qualifications

Auditing CAPA System Communication Skills Lean Principles Problem Solving Quality Assurance Regulatory Compliance Six Sigma Team Management Validation Protocols

Candidates must hold a degree or diploma in Engineering, Science, or Quality with at least 5 years of experience in the medical device industry. A Six Sigma Green Belt or higher is required, along with strong knowledge of ISO 13485 and FDA regulatory standards.

English

Company

Freudenberg Group

Freudenberg Group

linkedin
Motor Vehicle Manufacturing
Location
An Spidéal, Connacht, Ireland

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Excellent 4.7
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