Senior Quality Engineer

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.

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