Quality Engineering Manager

Embecta Corp.; Dún Laoghaire; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Competitive pay

Career growth opportunities

Health benefits

Job summary

A global diabetes care company is seeking a Quality Operations Manager in Dún Laoghaire, Ireland. You will lead the Quality Engineering Team, ensuring compliance with ISO standards and driving continuous improvement initiatives. The ideal candidate has a third-level qualification in Engineering or Science and over 5 years of experience in an ISO environment. This role offers a collaborative environment with opportunities for career growth and impact on the quality of medical devices.

Qualifications

• 5+ years in an ISO 9001/2000 or ISO 13485 environment.
• At least 3 years of supervisory experience with a proven track record.
• Familiarity with Statistical Process Control and Six Sigma.

Responsibilities

• Lead and develop the Quality Engineering Team.
• Ensure quality systems align with ISO standards.
• Manage key quality system elements and non-conformance processes.

Skills

Team development

Statistical Process Control

Problem-solving skills

Strong communication

Education

Third-level qualification in Engineering or Science

Tools

CAPA systems

ISO 9001/2000

ISO 13485

Job description

Quality Operations Manager page is loaded## Quality Operations Managerlocations: IRL Dun Laoghairetime type: Full timeposted on: Posted Yesterdayjob requisition id: R21-00607792embecta 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. For more information, visit or follow our social channels on , , and .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.**Responsibilities*** Be a key member of the Dun Laoghaire Quality Leadership Team and the site’s extended leadership team in addition to leading and developing the Quality Engineering Team.* Ensuring our quality systems align with ISO standards and ensure adherence to all embecta and external regulatory requirements.* Partner with production teams to drive continuous improvement initiatives* Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.* Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.* Oversee the activities of the Quality Control group* Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.* Build strong relationships with external customers,.* Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.**Education and Experience*** A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus* 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.* At least 3 years of supervisory experience with a proven track record of team development.* Experience preparing technical documentation and managing CAPA systems.* Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).* Knowledge of FDA requirements and experience managing FDA audits.* Experience with process validation, sterilization, and clean room environments is advantageous.* Strong interpersonal and communication abilities.* Exceptional problem-solving and analytical skills.* Ability to work effective in cross functional teams through collaboration* Proficient in standard business software and systems* **Purpose-Driven Work**: Make a tangible impact on the quality and safety of medical devices that improve lives.* **Collaborative Environment**: Work alongside passionate professionals in a culture that values teamwork and innovation.* **Career Growth**: Take your career to the next level with opportunities for professional development and leadership.* **Commitment to Excellence**: Be part of a company that is dedicated to upholding the highest standards in everything we do.#LI-ONSITE#LI-DF1embecta 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.