Maintain ISO 13485 certification. manager of ARTG Listed medical device and sponsor for the AU market.lead project to migrate a paper/electronic qms to new eQMS reducing paper and increasing visibility of the system. removed a TGA imposed condition from TGA certificate of conformity pulled together data and led projects, including submitting substantial changes to regulatory bodies. liaison with regulatory bodies to ensure compliance. reviewed labelling and artwork… Show more Maintain ISO 13485 certification. manager of ARTG Listed medical device and sponsor for the AU market.lead project to migrate a paper/electronic qms to new eQMS reducing paper and increasing visibility of the system. removed a TGA imposed condition from TGA certificate of conformity pulled together data and led projects, including submitting substantial changes to regulatory bodies. liaison with regulatory bodies to ensure compliance. reviewed labelling and artwork changes to ensure compliance to TGA advertising code. assist and lead design projects to confirm product inputs meet end user requirements.lead stability team to re-confirm product stability, including both accelerated aging and real-time Shelf-life studies. Interpreted stability data for lateral flow tests with assistance from scientists lead stage 1 and stage 2 audits to gain ISO 9001 Show less

Quality Manager of two entities: Authorised Representative for a ISO 15189/NATA/NPAAC accredited Pathology Laboratory and Management Representative of a ARTG listed ISO 13585 medical device manufacturing company. lead TGA/BSI/internal/supplier audits. manage a QA/QC team.

Experience in ISO 13485, ISO 14791:2019, ISO 15189, ISO 9001 and NPAAC requirements in day to day settings within a NATA accredited pathology laboratory and medical device manufacturing. -Investigating customer complaints, NCR, CAPA- trending data presented at metrics meetings - Lead Auditor accreditation (SAI Global) - leading critical supplier audits (ISO 9001:2015, ISO13485:2016, ISI 15189:2012 and supplier agreements) - Developing working relationships with… Show more Experience in ISO 13485, ISO 14791:2019, ISO 15189, ISO 9001 and NPAAC requirements in day to day settings within a NATA accredited pathology laboratory and medical device manufacturing. -Investigating customer complaints, NCR, CAPA- trending data presented at metrics meetings - Lead Auditor accreditation (SAI Global) - leading critical supplier audits (ISO 9001:2015, ISO13485:2016, ISI 15189:2012 and supplier agreements) - Developing working relationships with critical Suppliers - leading risk management review with a cross functional team, including DFMEA, PFMEA . - perform gap analysis on newly released regulatory regulations -Aiding supplier management - Writing validation protocols/Reports- Documentation Control - Supporting departments in QMS implementation and improvement -Continual improvement of processes within all departments - Release of product and components - Participating in external audits- Reviewing FMEA for both process, laboratory and design - Quality Control activities, incoming goods Show less

In charge of final product decisions and final release of products for critically ill patients. Involving in closing and resolving non conformances of products and processes

Organising a team of 30 within an aseptic environment, whilst being the point of call for any issues or problems that arise throughout the manufacturing process. A strong quality and business focus for all product decisions.

A hands on production technician skilled in all areas of aseptic compounding environment.