This high-tech international Medical Device specialist is looking for a QA/RA ‘executive chef’ to cook up a Regulatory degustation!
- Take 150+ years of combined medical device experience,
- Add numerous products for healthcare and laboratory –
- Then whisk in multiple business streams and specializations;
- A healthy dose of product innovation…
- Just a dash of laughing gas!
- Lashings of QMS at the core of the business,
- Stir over the gentle heat of an ASX Listing, and what do you get?
This great opportunity, that’s what!
Engaged in the worldwide manufacture of Medical Devices, this company has a proven track record when it comes to Quality and Product Performance. If you’ve ever visited a hospital, their products were all around you, saving lives, helping surgeons, delivering medicine, gases and solutions and transforming healthcare.
Quality is at the heart of this business, and there is space for an innovative and charismatic leader to step in and manage the QA/Regulatory function.
As the ‘executive chef’ of Quality and Regulatory Affairs, the Degustation menu goes something like this;
- Providing Quality and Regulatory oversight for the manufacturing function
- Mentoring a busy team of QA and Regulatory staff
- Leading the audit of internationally-located CMO’s under ISO 13485 guidelines
- Overseeing the NCR and CAPA processes with continuous improvement at the core
- Required to become the subject matter expert for all QA/RA-related issues
- Assisting with regulatory submissions and product documentation
- Managing the document control function
- Strengthening relationships with relevant regulatory authorities (TGA, BSI…)
- Building rapport, bridging gaps and defining Quality for the company
If you are degree qualified, have 5 or more years QA or Regulatory experience relating to the manufacture of Medical Devices, and like the sound of sitting at the head of your own table, then bring your Quality apron and let’s get cooking!