Senior Quality Associate

Direct message the job poster from Cyclomedica

We are Cyclomedica – bringing light into nuclear imaging since 1986. We have paved the way with nuclear medicine solutions in Australia and around the globe. From innovation, development to clinical practice applications – we are the world leaders in functional lung ventilation imaging with our proprietary technology: Technegas.

Created and manufactured in Australia our flagship product Technegas has revolutionised diagnostic lung imaging and today transform the lives of millions of patients in 66 countries around the world.

The site is FDA licenced for drug and device manufacturing and holds a TGA cGMP certificate as well as ISO:13485 certificate for the manufacture of its own CE marked Class IIb /IIa medical devices.

Join us as we continue to shape the future of nuclear medicine.

About the Role

We are seeking an experienced Senior Quality Associate to join our professional and committed team on a fixed-term contract for a period of 12 months. Reporting to the Head of Quality, this role is primarily responsible for supporting the management of the medical device / pharmaceutical Quality Management System ensuring continued compliance with the relevant regulations, guidelines and industry standards.

NB: The position is based on-site, five days a week.

Key Responsibilities

• Creation, review and approval of controlled documentation - assist in development and implementation of quality systems including writing, and review, of procedures and work instructions and training

• Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements

• Preparation of Product Quality Reviews

• Investigation and management of non-conformances, CAPAs, deviations and complaints

• Assistance with audit findings and audit management

• Cross-functional support of design and manufacturing and including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etc

• Conduct of other routine QA duties such as issue and review of batch documentation, incoming and finished goods release

• Plan and execute assigned process improvement projects

Required Skills and Experience

• University degree in Science, Engineering or equivalent

• At least four years' experience in GMP within Pharmaceuticals, Medical Devices or related field

• At least two years' experience in a QA role

• High level of verbal and written communication and numeracy skills

• Thorough knowledge of standards and governing bodies

• Excellent problem-solving skills

• Proficient attention to detail, excellent written and verbal communication skills

• Ability to work as part of a team

Why Join Our Team?

• Rare opportunity to join a company that manufactures both drug and medical device with exposure to FDA, TGA and European Notified Bodies.

• Competitive and attractive salary package

• Professional development opportunities

• Health and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membership

• Be part of an inspired and talented leadership team

• Company culture that values respect, collaboration, innovation and ethics

You will be joining an organisation that embraces diversity & inclusion.

We are committed to providing products, services and solutions that improve clinical outcomes everyday. If you feel the same – we would welcome your application

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing

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