I'm currently working an exciting new role with one of our clients based in South Dublin. My client is looking for someone coming from a Quality Engineering background within the medical device or pharma industry. The role is responsible for leading critical projects for new product introduction The incumbent will need manufacturing exposure. People management experience is also a must, as you will have a team of up to 7 people. This is a permanent role with strong base salary, bonus, pension, healthcare, share purchase scheme, life assurance etc.
Key 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 the company’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 & Experience Requirements
- 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.
- 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 audits
- Process Expertise: Experience in process validation, sterilization, and cleanroom environments is a plus.
