Quality Assurance Associate | Medical Devices & QMS

Emvision Medical Devices; Sydney; On-site; AUD 65,000 - 85,000; Full time

Job summary

EMVision Medical Devices is seeking an experienced QA Associate to support the implementation, maintenance and continual improvement of our QMS. You will provide operational and administrative quality support across documents, records, training administration and supplier management.

Reporting to the QA Manager, you will help ensure medical devices and activities comply with ISO 13485, MDR, MDSAP, FDA and other market regulations.

Qualifications

• Completed diploma, degree or other relevant tertiary qualification.
• Training in quality management systems or document control.
• Strong written and verbal communication skills.
• Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, PowerPoint).
• Ability to follow approved procedures and instructions.
• Reliable, responsible and willing to learn.
• Able to work collaboratively and communicate respectfully.
• Comfortable seeking guidance and escalating issues when required.

Responsibilities

• Provide administrative support for the maintenance of the QMS, including document and record control procedures.
• Perform formatting, uploading, archiving documents and records.
• Assist with drafting QMS documents using approved templates.
• Monitor actions and follow up on overdue items.
• Assist with quality events, including change controls, nonconformances, CAPAs, deviations and complaints.
• Maintain supplier qualification documents and approved supplier records.
• Escalate incomplete or incorrect documentation to the QA Manager.
• Execute QMS-related activities per EMVision procedures and work instructions.
• Assist with development and improvement of QMS processes.

Skills

Quality mindset

Communication skills

Attention to detail

Learning agility

Education

Diploma or degree

Tools

MS Office

Job description

EMVision Medical Devices is seeking an experienced QA Associate to support the implementation, maintenance and continual improvement of our QMS. You will provide operational and administrative quality support across documents, records, training administration and supplier management.

Reporting to the QA Manager, you will help ensure medical devices and activities comply with ISO 13485, MDR, MDSAP, FDA and other market regulations.