Senior Manager -Qa/Ra

The company:

We are a medical device manufacturer with ISO 13485/MDSAP certification, selling to over 65 countries around the world. We have been manufacturing medical devices in our North Geelong factory for the past 20 years. We require an experienced and passionate Senior Manager to head the Quality and Regulatory team.

Reporting to the Director, you will be responsible for the overall management of the quality system and regulatory requirements. The right candidate will display a proactive, hands-on leadership style interacting with all stakeholders within the company. 

Your role:

As the Senior Manager (QA/RA), you will be managing the QMS to be compliant with MDSAP requirements, ISO 13485:2016, MDR and all other regulatory requirements in the countries where we sell.

Duties will include;

• Lead the Design and Development process for new products and manage design changes.
• Conducting internal audits, supplier audits and facilitating external audits
• Managing audit responses, assigning and co-ordinating non-conformances as well as corrective and preventative actions and facilitating investigations
• Co-ordinating the execution of field actions and reporting to regulatory bodies if required;
• Conducting management review meetings
• Managing change control, deviations and promoting QA training throughout the organization.
• Provide regulatory support for our customers

Skills and Experience:

• Minimum 4 years previous experience in Quality Assurance, preferably in medical devices
• Detailed knowledge and experience in ISO 13485:2016
• Degree in science or Engineering is an advantage
• Hands on work experience

Salary is negotiable.

Preference will be given to candidates based in Greater Geelong and Western Suburbs in Melbourne or willing to relocate.

If you are interested please apply on the link below or send your CV along with a cover letter to *******@careessentials.com.au 

No recruitment agencies please.