Senior Quality Engineering & Validation Manager

Embecta; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

embecta is seeking an experienced Quality Engineering Manager to join its Dun Laoghaire site. You will lead Quality Engineering, Validation Engineering and Quality Control, ensuring ISO 9001 / ISO 13485 compliance and robust CAPA, non-conformance and incident processes across manufacturing and new product introduction.

You will drive process validation, apply SPC to production, support external audits, and lead continuous improvement initiatives including Six Sigma.

Qualifications

• 5+ years in a regulated ISO 9001 / ISO 13485 environment, ideally medical devices or pharmaceuticals.
• At least 3 years in a supervisory/people management role.
• Experience with process validation and CAPA system management.
• Knowledge of FDA requirements and support for FDA inspections.
• Knowledge of SPC and Six Sigma methodologies (Green Belt advantageous).
• Experience in sterilisation processes and cleanroom environments is advantageous.
• Strong communication and interpersonal skills with high computer literacy.

Responsibilities

• Lead process validation activities including review and approval of validation studies.
• Apply Statistical Process Control to live production processes.
• Provide day-to-day leadership of Quality Engineering, Validation Engineering and PQS.
• Support and maintain ISO Quality Systems and regulatory compliance.
• Act as a key quality contact for external customers and audits.
• Manage non-conformance, incident reporting, customer complaints and CAPAs.
• Drive improvements across Quality Assurance and Quality Control systems.
• Support production with continuous improvement including Six Sigma initiatives.
• Provide GMP oversight across production and quality activities.
• Prepare and maintain quality documentation in line with regulatory requirements.
• Contribute to Dun Laoghaire Quality Leadership Team and site leadership.

Skills

Leadership

Cross-functional collaboration

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in Engineering or Science

Postgraduate qualification advantageous

Tools

SPC

Six Sigma

CAPA management

Job description

embecta is seeking an experienced Quality Engineering Manager to join its Dun Laoghaire site. You will lead Quality Engineering, Validation Engineering and Quality Control, ensuring ISO 9001 / ISO 13485 compliance and robust CAPA, non-conformance and incident processes across manufacturing and new product introduction.

You will drive process validation, apply SPC to production, support external audits, and lead continuous improvement initiatives including Six Sigma.