Quality Engineering Manager

Baker Finn Recruitment; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Baker Finn Recruitment is seeking an experienced Quality Engineering Manager to join our Dun Laoghaire site, overseeing product quality, process improvement and customer engagement across manufacturing and new product introduction activities.

Reporting to site quality leadership, you will lead Quality Engineering, Validation Engineering and Quality Control, ensuring ISO 9001/13485 compliance, GMP standards and regulatory requirements, while driving continuous improvement and coordinating with

Qualifications

• Minimum 5 years’ experience in a regulated ISO 9001 / ISO 13485 environment.
• 3+ years in a supervisory or people management role.
• Experience with process validation and CAPA system management.
• Working knowledge of FDA requirements and supporting FDA inspections.
• Knowledge of SPC and Six Sigma methodologies (Green Belt advantageous).
• Experience preparing and managing technical documentation.
• Experience in sterilisation processes and cleanroom environments is advantageous.

Responsibilities

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

Skills

Quality engineering

Validation engineering

CAPA management

Six Sigma

SPC

Cross-functional teamwork

People management

Regulatory compliance

ISO 9001

ISO 13485

Job description

We are seeking an experienced Quality Engineering Manager to join our Dun Laoghaire site. This role plays a key part in supporting product quality, process improvement, and customer engagement across manufacturing and new product introduction activities.

Reporting into site quality leadership, you will provide operational and people leadership across Quality Engineering, Validation Engineering, and Quality Control, while ensuring strong compliance with ISO, GMP, and regulatory requirements.

Responsibilities

• Lead process validation activities, including the review and approval of validation studies.
• Apply Statistical Process Control (SPC) to live production processes to support quality and process performance.
• Provide day-to-day leadership of the Quality Engineering function, including Quality and Validation Engineers and Product Quality Setters (PQS).
• Support and maintain ISO Quality Systems and ensure compliance with company standards, regulatory requirements, and external audits.
• Act as a key quality contact for external customers.
• Manage core quality systems supporting production, including non-conformance management, incident reporting, customer complaints, and CAPAs.
• Drive improvements across Quality Assurance and Quality Control systems.
• Support production teams with continuous improvement initiatives, including Six Sigma activities.
• Provide GMP oversight across production and quality engineering activities.
• Prepare and maintain quality and technical documentation in line with regulatory requirements.
• Contribute as a member of the Dun Laoghaire Quality Leadership Team and site extended leadership team.

Requirements

• Minimum of 5 years’ experience working in a regulated ISO 9001 / ISO 13485 environment, ideally within medical devices or pharmaceuticals.
• Minimum 3 years’ experience in a supervisory or people management role.
• Experience with process validation and CAPA system management.
• Working knowledge of FDA requirements and experience supporting FDA inspections.
• Knowledge of Statistical Process Control and Six Sigma methodologies (Green Belt advantageous).
• Experience preparing and managing technical documentation.
• Experience in sterilisation processes and cleanroom environments is advantageous.
• Proven ability to work effectively in cross-functional teams.
• Strong communication and interpersonal skills, with a high level of computer literacy.