Posted: 17th December 2023
People and Culture Manager – Sydney, Australia
We are Cyclomedica – bringing light into Molecular Imaging since 1986. We have paved the way with Molecular Imaging solutions in Australia and around the globe. From innovation and 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 transforms the lives of millions of patients in more than 64 countries worldwide.
The site is FDA-licenced for drug and device manufacturing. It holds a TGA cGMP certificate and an ISO:13485 certificate for manufacturing its own CE-marked Class IIb /IIa medical devices.
About the role
We are seeking an experienced Quality Associate to join our professional and committed team. 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. This is an on-site role.
- 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
Skills, Attributes, and Experience
- Demonstrated ability to build key business relations with management, key stakeholders, employees, external parties and the People and Culture team
- Customer service and strong delivery ethic, as well as demonstrated initiative
- Well-developed coaching and negotiating skills
- Superior organisation, coordination and time management skills to balance conflicting priorities
- Advanced-level computer literacy
- Understanding of awards, acts, enterprise agreements and all other relevant legislation
- Relevant degree qualification
- Minimum 8 years of generalist People and Culture experience
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.
Cyclomedica is committed to providing products, services and solutions that improve daily clinical outcomes. If you feel the same way, we invite you to submit your application using the form below!
We look forward to hearing from you,
The Cyclomedica Team