Quality Assurance Specialist

Position Title: Quality Assurance Specialist

Location – Ventura

Reports to: Quality Assurance Manager

Compensation: 60 - 80K DOE plus annual bonus

AVITA Medical is a therapeutic, acute wound care company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patients’ own skin to create Spray-On Skin cells.

We believe that 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, and integrity is essential to our success.

Position Summary:

Assist with Avita Medical QMS related Systems (Complaints and NCPs) and support manufacturing quality systems at the AVITA Medical production stie. Follow established procedures and policies set forth by AVITA Medical and complete tasks as required.

Key Responsibilities:

Support manufacturing of Silicone and elastomer products.

Assist with tasks associated with Customer Feedback/Complaints process including:

• Receipt and input of customer feedback/complaint information into system
• Coordination of returns analysis
• Complaint device evaluation
• Maintenance of complaints database
• Development of complaint evaluation procedure/process for new product(s)

Assist with tasks associated with non-conforming products (NCP) process including:

• Maintenance of NCP (non-conformance) system
• Product disposition and root cause analysis

Assist in the maintenance of applicable e-QMS modules

Support maintenance of all quality records and documentation in accordance with the quality manual

Other responsibilities as assigned by supervisor

Job Requirements:

• Experience working with Silicone and elastomer products
• Strong computer skills: Microsoft Office (Word & Excel) and Adobe Acrobat
• Written and oral communication skills
• Ability to work on multiple tasks simultaneously
• Ability to work independently and as a member of a team
• Familiarity with requirements related to traceability, compliance, risk and product manufacturing

Education/Experience

• 3 - 5 years’ medical device industry experience
• Experienced in applicability of ISO 14971:2019, ISO 13485:2016, EUMDR and 21 CFR 820 regulations.
• Experienced in the use of electronic Quality Management Systems and database administration.

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.

MFG

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.