Quality Manager

1 week ago

County Dublin, Ireland Pm Group Full time

Overview PM Group's OTS (Outsourced Technical Services) department are currently seeking to recruit a Quality Manager to be based in our clients Medical Devices facility based in South Dublin.
The successful candidate will be responsible for leading critical projects for new product introduction.
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 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.
Qualifications Educational Requirements and Relevant Experience: Industry Experience : At least 5 years in an ISO 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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