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. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.
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.
The Quality Engineering Manager - NPI will lead critical projects for new production introduction at embecta Dun Laoghaire by providing leadership to a Quality Engineering Team of 5-7 associates managing validation studies and collaborating with various internal and external stakeholders
Responsibilities:
- Support ISO9000/ISO13485 Quality Systems: Ensuring the company's quality management system aligns with these international standards, which are crucial in the medical devices/pharmaceutical industry.
- Regulatory Compliance: Ensuring that all activities meet embecta’s and external regulatory requirements.
- Leadership Role: Being a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation.
- Continuous Improvement: Supporting programs like Six Sigma to enhance processes and product quality.
- Quality System Management: Overseeing systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis.
- Customer Interaction: Liaising with key external customers, to ensure that quality standards meet customer expectations.
- CAPA Management: Ensuring Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards.
- GMP Oversight: Ensuring Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
- Documentation: Preparing and maintaining documentation to meet regulatory requirements.
Education and Experience
- At least 5 years in an ISO 9001/13485 environment, preferably in the medical devices or pharmaceutical industry.
- 3 + years in a supervisory role, indicating the need for leadership skills
- Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required. Experience with FDA requirements and audits
- Experience in process validation, sterilization, and cleanroom environments is a plus.
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.
