We are seeking an experienced Senior Quality Manager to oversee the Quality Assurance function within our clients Limerick-based medical device manufacturing facility.
This role will be instrumental in ensuring product quality and compliance with regulatory requirements, driving continuous improvement, and leading quality initiatives.
The successful candidate will manage a team of quality professionals, work cross-functionally to embed quality into all processes, and ensure that products meet the highest standards of safety and efficacy.
Key Responsibilities Quality System Management: Oversee and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant standards and regulations.
Regulatory Compliance: Ensure that all quality assurance activities are in full compliance with regulatory requirements, including documentation, audits, and submissions.
Audit Management: Lead internal and external audits, including FDA, Notified Body, and customer audits.
Address findings promptly, ensuring that corrective and preventive actions (CAPAs) are effectively implemented.
Team Leadership and Development: Manage, mentor, and develop the quality assurance team, fostering a culture of quality, accountability, and continuous improvement.
Risk Management: Implement and oversee risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments, ensuring the consistent identification and mitigation of quality risks.
Supplier Quality: Develop and manage supplier quality programs, conduct supplier audits, and implement quality agreements with suppliers to ensure incoming materials meet specified quality standards.
CAPA Management: Oversee the CAPA process, ensuring timely investigation, root cause analysis, and implementation of corrective actions, with a focus on reducing recurrence.
Product Life-cycle Support: Provide quality support across product life-cycle stages, including new product development, manufacturing, and post-market surveillance.
Process Improvement: Drive continuous improvement initiatives to optimise quality processes, reduce product defects, and improve manufacturing and operational efficiency's.
Customer and Complaint Handling: Oversee complaint investigations, trend analysis, and customer feedback processes, ensuring timely resolution and compliance with regulatory reporting requirements.
Data Analysis and Reporting: Develop and monitor key quality metrics (KPIs), prepare quality reports, and present findings and improvements to senior management.
Essential Qualifications and Skills Education: Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
Advanced degree (e.g., Master's or Ph.D.) is an advantage 10+ years of experience in quality assurance within the medical device or related regulated sector, with at least 5 years in a managerial role.
Strong understanding of ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations and standards.
Demonstrated success in managing a Quality Management System in a highly regulated environment.
Proven experience in managing internal and external audits, CAPA processes, and supplier quality management.
Technical Skills: Proficiency in quality management tools, including QMS software, statistical analysis tools, and risk management methods.
Familiarity with process validation, design control, risk management techniques (e.g., FMEA), and root cause analysis tools.
Strong knowledge of product life-cycle quality, including experience with post-market surveillance and complaint handling.
Soft Skills: Strong leadership skills with a proven ability to lead and motivate a team.
Excellent communication and presentation skills for cross-functional collaboration and stakeholder reporting.
Analytical mindset with attention to detail and the ability to identify and implement improvement opportunities.
Preferred Qualifications Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or other relevant quality certifications (e.g., Six Sigma, ASQ).
Experience in Lean Manufacturing, Six Sigma, or similar methodologies for process improvement.Familiarity with regulatory submission requirements for the medical device industry.
What We Offer Competitive salary and comprehensive benefits package.
A collaborative work environment with opportunities for advancement.
Support for continuous professional development and training.
Involvement in meaningful work that positively impacts patients and healthcare.
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For more information and a confidential chat please contact Niall Finnerty on (phone number removed)/ (url removed)