TEC Partners is pleased to have partnered with a pioneering medical device company dedicated to improving the quality of life for patients through next-generation orthopedic implant devices. Through events, resources, and patient information, my client aims to empower both medical professionals and patients on their journey to improved orthopedic health.
As the Quality Specialist, you will play a pivotal part in upholding the company's commitment to quality and compliance with ISO 13485 standards. As a key member of the quality assurance team, you will be responsible for conducting internal audits, leading lean manufacturing initiatives, driving supply chain improvements, and conducting supplier audits to ensure the highest standards of product excellence.
Quality Specialist Responsibilities:
- Conduct internal audits to ensure adherence to quality management systems and regulatory requirements
- Lead lean manufacturing initiatives to optimise processes and drive operational efficiency
- Collaborate with cross-functional teams to identify areas for improvement and implement corrective actions
- Drive continuous improvement initiatives throughout the supply chain to enhance product quality and reliability
- Conduct supplier audits to evaluate performance and ensure compliance with quality standards and regulatory requirements
- Develop and maintain documentation related to quality management systems and regulatory compliance
- Provide guidance and support to team members on quality assurance processes and best practices
Quality Specialist Requirements:
- Bachelor's degree in a Scientific related field or equivalent experience in a commercial manufacturing organisation
- Minimum of 3 years of experience in quality assurance within the medical device industry
- Strong knowledge of ISO 13485 standards and regulatory requirements
- Experience conducting internal audits and supplier audits
- Proficiency in lean manufacturing principles and process improvement methodologies
- Excellent communication and interpersonal skills
- Ability to work effectively in a fast-paced, dynamic environment and collaborate with cross-functional team
If you are passionate about quality assurance and committed to driving excellence in orthopedic implant devices, please apply with an up to date CV.