Job Title: Quality Operations Manager
We are seeking a skilled Quality Operations Manager to lead our team in Dun Laoghaire. As a key member of the site's leadership team, you will be responsible for maintaining the highest standards of quality and compliance.
Key Responsibilities:
* Quality Leadership: Ensure our quality systems align with ISO standards and regulatory requirements.
* Team Management: Lead, inspire, and develop the Quality Engineering Team.
* Continuous Improvement: Drive continuous improvement initiatives using Six Sigma methodologies.
* System Oversight: Manage key quality system elements, including non-conformance processes and customer complaint analysis.
* Quality Control: Oversee the activities of the Quality Control group.
* Drive Change: Lead key improvements in quality assurance and control systems.
* Collaborate Externally: Build strong relationships with external customers.
* Regulatory Excellence: Ensure timely and compliant completion of CAPAs and prepare for audits with confidence.
* GMP Compliance: Provide oversight and ensure GMP standards are consistently met.
Requirements:
* A third-level qualification in Engineering or a Science discipline is required.
* 5+ years in an ISO 9001/2000 or ISO 13485 environment.
* 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.
* Knowledge of FDA requirements and experience managing FDA audits.
About Embecta:
We are a global diabetes care company dedicated to empowering people with diabetes to live their best life through innovative solutions, partnerships, and the passion of our employees. Our Total Rewards program includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components.
The estimated salary for this position is €80,000 - €110,000 per year, depending on qualifications and experience.