QA & Compliance Specialist — GMP/ISO (1+ Yr Exp)

Fresenius Medical Care; Sydney; On-site; AUD 90,000 - 115,000; Full time

Job summary

Fresenius Medical Care in Australia is seeking a Quality Assurance Officer - QMS, Products to support GMP/ISO compliant QA activities. You will perform sampling, testing, and data recording, ensuring all operations meet GMP, NID and ISO standards while assisting with internal audits and QA process improvements.

The role requires a tertiary science qualification and at least 1 year in a GMP/Medical Devices/ISO certified environment, with strong communication and computer literacy to manage high

Qualifications

• Minimum 1 year experience in GMP/Medical Devices/ISO environment.
• Excellent written and verbal communication skills.
• Ability to manage a high throughput of work with quality deadlines.
• Strong computer literacy and data recording skills.

Responsibilities

• Perform sampling and testing according to SOPs.
• Ensure activities meet GMP and ISO guidelines and FMC standards.
• Assist in internal audits for compliance with FMC quality systems.
• Carry out other projects as directed by QA Manager/Lab Supervisor.
• Maintain safe working practices and WHS compliance.

Skills

QA experience

GMP knowledge

ISO knowledge

Documentation skills

Communication skills

Computer literacy

Education

Tertiary qualification in science

Job description

Fresenius Medical Care in Australia is seeking a Quality Assurance Officer - QMS, Products to support GMP/ISO compliant QA activities. You will perform sampling, testing, and data recording, ensuring all operations meet GMP, NID and ISO standards while assisting with internal audits and QA process improvements.

The role requires a tertiary science qualification and at least 1 year in a GMP/Medical Devices/ISO certified environment, with strong communication and computer literacy to manage high