Quality Engineering 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

Job Description

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. 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 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. Requirements Third-level qualification in Engineering or a Science discipline (postgraduate qualification advantageous). Minimum of 5 years' experience working in a regulated ISO 9001 / ISO 13485 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 (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. #LI-ONSITE #LI-DF1 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. TPBN1_IJ