Quality Engineering Manager

4220 embecta Penel Irish Branch; Dún Laoghaire; On-site; EUR 70,000 - 90,000; Full time

Job summary

The 4220 embecta Penel Irish Branch is seeking an experienced Quality Engineering Manager for its Dun Laoghaire site. This vital role involves leading quality management efforts, ensuring compliance with ISO standards, and driving continuous improvement initiatives.

You will oversee process validation, support cross-functional teams, and provide leadership within the Quality Engineering function. Candidates should possess a relevant qualification and extensive experience in regulated environments, ideally within medical devices. The role emphasizes collaboration, process optimization, and technical documentation.

Qualifications

• Minimum of 5 years’ experience in a regulated ISO 9001 / ISO 13485 environment.
• At least 3 years’ experience in a supervisory or people management role.
• Knowledge of Statistical Process Control and Six Sigma methodologies.

Responsibilities

• Lead process validation activities and review validation studies.
• Manage core quality systems supporting production and compliance.
• Drive improvements across Quality Assurance and Quality Control systems.

Skills

Quality Assurance

Process Validation

Statistical Process Control

Leadership

Communication Skills

Education

Third-level qualification in Engineering or Science

Tools

ISO 9001

ISO 13485

FDA Regulations

Six Sigma

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.

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 embecta 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.

Qualifications

• Third‑level qualification in Engineering or a Science discipline (postgraduate qualification advantageous).
• Minimum of 5 years’ experience working in a regulated ISO 9001 / ISO13485 environment, ideally within medical devices or pharmaceuticals.
• At least 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 (GreenBelt 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.

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.