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Location:
Wicklow
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Next Generation
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Contact email:
barry.omahony@nextgeneration.ie
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Job ref:
JOB-14135_1747398145
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Published:
about 20 hours ago
Are you a proactive quality professional ready to take the lead in driving compliance and continuous improvement in a dynamic medical device environment? My client is looking for a Senior Quality Engineer to join their team and play a critical role in upholding the highest standards of quality and regulatory compliance.
Key Responsibilities
- Lead and manage root cause investigations, NCRs, and CAPA implementation to ensure timely and effective resolutions.
- Support the Quality Assurance Manager with day-to-day Quality Management System (QMS) operations in line with ISO 13485 and applicable regulatory requirements.
- Conduct and support internal audits to drive ongoing compliance and continuous improvement.
- Oversee and support validation activities, including process and test method validations, and risk assessments.
- Provide hands-on quality support to manufacturing, ensuring product compliance and robust process control.
- Develop, implement, and maintain SOPs and work instructions that align with quality initiatives and operational needs.
- Act as a key liaison for customer complaints and regulatory inquiries, leading investigations where necessary.
- Champion continuous improvement initiatives to enhance efficiency and product quality.
- Mentor and support junior members of the quality team, fostering a culture of learning and growth.
- Support supplier quality management, including the establishment of quality agreements and compliance monitoring.
- Own and manage preventive maintenance and calibration schedules.
- Assist with the ongoing development and training of the broader quality team.
Requirements
- Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline.
- 5+ years of experience in a medical device or regulated manufacturing environment.
- Proven expertise in root cause analysis, CAPA systems, and failure investigations.
- Internal auditor training in ISO 13485 (Lead Auditor certification is a plus).
- Solid knowledge of quality engineering tools: FMEA, SPC, risk management, and validation practices.
- Strong analytical and problem-solving skills with a data-driven approach.
- Excellent interpersonal and communication skills with a collaborative mindset.
- Proficiency in Microsoft Office Suite and experience with quality management software.
The Next Step for you:
Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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