Title: QA Manager
Company Name: Pettit Pharma & Device Search Pty Ltd
Job Location: Sydney, North Shore & Northern Beaches
Employment Status: Full Time
THE COMPANY YOU WOULD BE JOINING
- This global device leader, prides itself on its culture of empowerment, giving their people flexibility and autonomy to pave their own way, while providing them with all the support and training they need to succeed.
- They lead the way in innovation, new product development and medical education. With a mission of helping their surgical customers improve patient outcomes.
- They continue to experience extraordinary growth and demand for their products globally which has created new positions, including this one.
WHAT’S IN IT FOR YOU
- What do their employees say about them, “I love every part of being in this company, the people are great, the benefits are amazing and you make medical devices to help improve peoples' quality of life, everything is top notch. Good place to work, good benefits and great company culture”.
WHAT YOU WILL LEAD, GROW & BE A PART OF
- This QA Manager role will be responsible for all quality related activities for ANZ and will manage the Quality Management System and coordinate daily quality activities in the region working closely with APAC Quality team.
- This role will manage compliance to corporate quality requirements affecting regional company operations and products and report the performance of the quality system to relevant authorities. Areas of responsibility may include but are not limited to; Documentation Controls, Corrective Action Preventive Action, Post Market Surveillance and QMS auditing.
- You will establish a document management system for ANZ document control ensuring accuracy and completeness as well as document security and collaborate with QMS stakeholders across the organization to drive continuous improvement of the QMS and related processes.
- You will ensure the effective implementation of processes across ANZ and manage and lead post-market regulatory activities such as complaint management, field actions and adverse event reporting in ANZ.
- You will manage and schedule internal and external audits and initiate internal corrective actions necessary to ensure overall quality compliance and perform internal and external quality audits, issuing related corrective actions.
- You will provide leadership, management, and development of the Quality Assurance Associate who will be a direct report in your team.
WHAT QUALS, EXPERIENCE & SKILLS WILL YOU NEED TO GET THE JOB?
- University degree required, preferably in a Science or Engineering or similar.
- 10 years of direct experience in administration of quality system elements within a medical device organisation within the ANZ market.
- Knowledge and a clear understanding of TGA and MEDSAFE regulations and ideally some exposure/knowledge of the FDA.
- Working experience in implementation and maintenance of the ISO 13485:2016 standard.
- Strong interpersonal, English oral and written communication skills.
- Strong project management skills.
- Ideally comprehension of orthopaedic technical/engineering/medical terminology.
Please 'apply now' by quoting reference number 2988. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.