Quality Manager

1 week ago

Brisbane, Australia Pfizer Full time

Why Patients Need You

Pfizer Australia has recently acquired ResApp Health. ResApp is developing digital healthcare solutions to assist doctors and empower patients to diagnose and manage respiratory disease. We are a small team combining cutting-edge technology with world-class science to deliver breakthrough mobile health solutions and solve real healthcare problems.

What You Will Achieve
- This role is directly responsible for managing and reporting on all aspects of the quality management system (QMS) for Digital Health and Medicines. This includes coordinating and monitoring information and documented standards from across all areas of the business
- Ensure the QMS is maintained, complete and compliant with the Quality Manual, SOPs and applicable standards and regulations
- Ensure that all corrective and preventive action reports are implemented and verified for effectiveness
- Ensure that all changes to the QMS documents or processes are documented as per document control or control of record SOPs
- Ensure that all related documents for the management reviews are prepared and correct within set timeframes
- Maintain control of documents and records pursuant to relevant SOPs

How You Will Achieve It
- Write, review and maintain all controlled documents to ensure the QMS remains compliant to the relevant standards
- Keep all document logs updated
- Identifying deficiencies related to the quality system
- Initiating preventative and corrective actions to prevent recurrence of non-conformances
- Coordinate management review meetings, including setting times, agendas and review documents
- Coordinate internal and notified body audits
- Ensure all changes are trained to the appropriate staff
- Ensure all training is recorded
- Collate and present all data provided for products or processes within the QMS to present to the management review meetings
- Handle and resolve all customer complaints and feedback

**Qualifications**:
Must-Have
- 5+ years’ experience
- Degree Science, Engineering, Pharmacy or Law or similar. Qualification and experience with quality management systems, quality management system auditing, medical device quality systems or regulations. Project Management or similar
- Experience managing Quality Management Systems (QMS) and continuous improvement systems in previous roles
- A hands-on QA background with 4+ years' experience in a medical device quality systems, regulations and processes.
- Sound project management / organisational skills
- High level of attention to detail, initiative and strong work ethic
- Strong communication skills with all the key stakeholders to ensure QA vision is understood and implemented correctly
- Knowledge of QA targets and measures

Nice-To-Have
- ISO 13485:2016 or equivalent
- Experience in the healthcare or biotechnology industry

Work Location Assignment: Flexible

Information & Business Tech

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