FDA Quality Engineer – Medical Devices
A Quality Assurance Engineer is required for a small fantastic global Medical Devices company - working at the Global HQ in Melbourne! Broad role.
Summary about this job
Pharmaceuticals & Medical Devices
Company: i-Pharm Consulting Australia Pty Ltd
Location: Melbourne
Work type: Full Time
Salary: n\a
Phone: +61-3-4424-9327
Fax: +61-8-1675-6600
E-mail: n\a
Site: n\a
Detail information about job FDA Quality Engineer – Medical Devices. Terms and conditions vacancy
ROLE/DESCRIPTION
- Broad based Quality Systems Management role supporting management
- FDA experience
- Maintain Quality Management system
21CFR820 and other standards relevant to the design, development, manufacture and distribution of the product. - Manage the document control function
- QMS Matrix training
- Process validation
- Provide oversight on CA/PA related activites
- management of product quality process for ANZ
- exciting and passionate team
- REQUIREMENTS
- Life sciences degree (pharmacy preferred)
- Experience with TGA & Medsafe
- ISO 9001 / 13485 knowledge
- process validation
- Regulatory product submissions / TGA and Medsafe
- People management would be a bonus
- Electronic QMS in a medical device setting
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
www.i-pharmconsulting.com
TO APPLY
If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email [email protected]. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
KEY WORDS
Senior Quality Assurance Associate, Quality Engineer, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Engineer, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Regulatory Associate, Senior Regulatory Associate, Submissions/Documentation, QMS, CAPA, ISO 13485.