Job Title: Quality Management Specialist
The role of Quality Management Specialist is a vital position within our organization, responsible for leading the development and implementation of quality management systems.
Key Responsibilities:
* Develop and maintain a comprehensive quality management system that ensures compliance with regulatory requirements and industry standards.
* Liaise with cross-functional teams to ensure effective implementation of quality management systems.
* Conduct regular audits to identify areas for improvement and implement corrective actions as needed.
* Maintain expertise in current and emerging regulations and standards impacting medical devices and combination products.
* Provide training and support to employees on quality management systems and procedures.
Requirements:
To be successful in this role, you will need:
* A Bachelor's degree in engineering, physical science, life science or pharmacy.
* A minimum of 7 years of industry experience in a GXP regulated environment.
* ISO 13485 Lead Auditor certification by a professional body.
* Additional accreditation such as Six Sigma Black Belt Certification or Project Management Professional (PMP) Certification.
* Excellent communication and interpersonal skills.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.
This is a hybrid role with 3 days on site and 2 days remote work arrangement.