Quality Engineer

4 weeks ago

Athlone, County Westmeath, Ireland Signature Orthopaedics Full time

Quality Engineer
About the Role
Signature Orthopaedics Europe, a leading manufacturer in the orthopaedic implant sector, is seeking an experienced Quality Engineer to join our team.
This role is critical in ensuring the highest quality standards and regulatory compliance in our medical device manufacturing processes.
The ideal candidate will have 2-3 years of experience in medical device manufacturing, preferably within orthopaedics, and possess a strong technical foundation in quality systems and engineering.
Key Responsibilities
Oversee and maintain the Quality Management System (QMS) ensuring compliance with ISO 13485, FDA, MDR, and other applicable regulations.
Lead and execute quality engineering activities including risk assessments, root cause analysis, CAPA, change control, and supplier quality management.
Support product development and manufacturing by reviewing technical documentation and design transfer activities.
Perform and coordinate internal and external audits, manage audit responses and follow-up corrective actions.
Collaborate with cross-functional teams including manufacturing, engineering, and regulatory affairs to resolve quality issues and implement process improvements.
Manage non-conformance reports (NCRs) and ensure timely investigation, documentation, and resolution.
Provide training and guidance on quality processes, regulatory requirements, and best practices to staff at various levels.
Qualifications
Bachelor's degree in Engineering, Quality, or related field preferred.
2-3 years' experience in a quality engineering or quality assurance role within the medical device manufacturing industry.
Strong knowledge and practical application of ISO 13485, FDA QSR, MDR requirements.
Experience with QMS documentation, CAPA, audits, risk management, and change control.
Proficiency in problem-solving, root cause analysis, and quality data analysis tools.
Ability to work collaboratively across departments in a regulated environment.
Preferred Qualifications
Certification in Quality Engineering, Six Sigma, or related quality management disciplines.
Experience with statistical process control (SPC), process validation, and supplier quality management.
Familiarity with orthopaedic implant manufacturing processes and cleanroom environments.
Proficiency in quality software such as Minitab, Q-Pulse, or equivalent tools.
This is an exciting opportunity for a skilled Quality Engineer looking to advance their career in the medical devices industry.
If you meet the requirements and are passionate about precision engineering and quality assurance, we encourage you to apply.
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