Quality Assurance Expertise
We are seeking a highly experienced Quality Systems Specialist to join our MedTech company. The role will be responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable national and international regulations, including FDA 21 CFR Part 820, ISO 13485, ISO 27001, and other relevant requirements.
Key Responsibilities:
* Maintain the QMS and activities to ensure full compliance with regulatory requirements.
* Develop and maintain quality system procedures, work instructions, and records.
* Ensure timely document control and change management activities.
* Track and report metrics and key performance indicators for the QMS.
* Monitor and trend quality system metrics.
* Support Corrective and Preventive Actions by conducting investigations and documentation.
* Collaborate with departments to assess the effectiveness of the QMS and improve processes.
* Manage the Internal Audit program.
* Support client quality audits and address findings.
* Document Control - manage SOPs and Document Control.
* Site lead for training compliance to SOPs.
* Other duties as required to support the growing Quality organisation.
Essential Criteria:
* Flexibility to travel to the US for business activities and Quality Audits.
* Bachelor's degree in a Science-related discipline.
* Minimum 3-5 years' experience in Medical Device industry within a Quality Assurance role.
* Experience with Medical Device software an advantage.
* Strong knowledge of current QMS requirements and extensive experience in ISO 13485.
* Proven ability to communicate clearly with stakeholders.
* Strong organisational and presentation skills.