Key Leadership Role:
This leadership position oversees the Quality Engineering Team in a medical devices/pharmaceutical industry setting. The ideal candidate will have at least 5 years of experience in an ISO 9001/13485 environment and 3+ years of supervisory experience.
Main Responsibilities:
* Ensure alignment with international quality standards by supporting ISO 9000/ISO 13485 Quality Systems.
* Maintain regulatory compliance by ensuring all activities meet embecta's and external regulatory requirements.
* Lead the Quality Engineering Team through daily management, performance reviews, and delegation.
* Sustain continuous improvement programs like Six Sigma to enhance processes and product quality.
Required Skills and Qualifications:
* A minimum of 5 years in an ISO 9001/13485 environment, preferably in the medical devices or pharmaceutical industry.
* At least 3 + years in a supervisory role, demonstrating leadership skills.
* Familiarity with Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous.