QUALITY ASSURANCE ENGINEER | MEDICAL DEVICES

Summary about this job

Detail information about job QUALITY ASSURANCE ENGINEER | MEDICAL DEVICES. Terms and conditions vacancy

• UPTO $95K BASE FIGURE + SUPER + PRIVATE HEALTH + MORE ADDED BONUSES
• PRIME SOUTHEAST LOCATION | WORLD LEADING PRODUCTS
• GLOBAL BRAND - GREAT WORK LIFE BALANCE

My client is a key player within the Medical Devices industry & due to sustained growth over the year they are currently looking to add a Quality Engineer to their already experienced team.
As a Quality Engineer your key responsibilities will include:

• Lead and manage quality engineering support in production & distribution areas ensuring compliance to quality standards and specifications, GMPs of all medical device regulatory agencies (eg. TGA & ISO).
• Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective/preventive actions to improve product quality and output.
• Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
• Review and assessment of all quality records (e.g. batch documentation, calibration, incoming quality inspection, finished goods quality inspection, sterilization batch records).
• Provide guidance, direction, and supervision of QA Team members where appropriate
• Develop, and present Quality Performance Information as required
• Deputize for QA/Regulatory Affairs Manager, as required

In order to apply for this role you will have the relevant tertiary qualification & have experience of working as a quality engineer (within the Medical industry) while possessing excellent communication skills (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external. You must have good working knowledge of regulatory standards (Therapeutic Goods (Medical Devices) Regulations, ISO 13485 Quality System Standard, ISO 14971 Risk Management, ISO 11135 Sterilization of health-care products - Ethylene oxide strongly preferred) and industry practices along with experience of applying Lean Six Sigma technique in a business situation. In addition to this you will have a passion for data, analysis, trends, reporting. Ability to read and interpret documents. Project management skills are important in this role & having the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.