Quality Manager

This involves providing leadership to the Quality Engineering team (5-7 associates) , managing validation studies, and working closely 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
• 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.
• Educational Requirements and Relevant Experience:
• Industry Experience: At least 5 years in an ISO 9001/13485 environment, preferably in the medical devices or pharmaceutical industry.
• Supervisory Experience: A minimum of 3 years in a supervisory role, indicating the need for leadership skills.

Knowledge, Skills and Abilities:

• Technical Knowledge: Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required.
• Regulatory Knowledge: Experience with FDA requirements and audit
• Process Expertise: Experience in process validation, sterilization, and cleanroom environments is a plus.

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