Quality Assurance Technician

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Description

Welcome to the future of wound care. AVITA Medical is a therapeutic, acute wound care company leading the development and commercialization of novel wound therapy technologies and skin reconstruction solutions designed to Heal at the Speed of Life. Our portfolio includes the RECELL System, which uses a patient's own cells to stimulate healing and repigmentation in the wound bed, Cohealyx, a collagen dermal matrix to support cellular migration and revascularization, and PermeaDerm, a biosynthetic wound matrix that serves as a wound temporizer or primary dressing.

As an organization, we believe:

• Patients are at the heart of everything we do
• Our employees are the lifeblood of AVITA Medical
• Passion is key to making a difference
• Quality impacts everything we do
• Integrity is essential to our success

The Quality Assurance Technician will assist with AVITA Medical QMS processes (Complaints and NCP) and support manufacturing quality systems at the production site, following established procedures and policies.

Requirements

• 3-5 years of experience in a medical device or regulated industry, or
• 2-3 years of experience with an Associate's or Bachelor's degree in a technical or scientific field
• Working knowledge of quality system regulations (21 CFR 820, ISO 13485, ISO 14971)
• Experience with electronic Quality Management Systems (eQMS)
• Basic understanding of inspection methods and quality data collection
• Proficiency in Microsoft Office, particularly Excel

Responsibilities

• Receive, review, and accurately enter customer feedback and complaint data into the eQMS
• Coordinate and track returned products, including support of return analysis
• Support complaint investigations through device evaluation, inspection, and data collection under Quality Engineering guidance
• Maintain the complaints database to ensure accuracy, completeness, and traceability
• Assist in developing and implementing complaint evaluation procedures for new products
• Support Post Market Surveillance (PMS) activities by compiling data and maintaining required records
• Support Nonconforming Product (NCP) processes, including documentation, product disposition, and participation in root cause analysis under supervision
• Maintain accurate and compliant records within eQMS, ensuring proper data entry and record retention
• Ensure quality records comply with the Quality Manual, internal procedures, and regulatory requirements
• Perform other quality-related duties as assigned

AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.

Your Physical Work Environment Will Require: The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and/or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus. The individual is frequently required to reach with hands and arms, and repetitive motion. The individual is occasionally required to stoop, kneel, or crouch. The individual may occasionally lift and/or move up to 25 pounds.

The employee could be exposed to heat and cold weather, noise, and oils as well as subjected to hazards such as, but not limited to, moving parts and vehicles, heat, and chemicals and electrical current.

AVITA Medical is an E-Verify participant.

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.

Salary Description

$31.00 - $35.00/hour