Quality Engineer

Position Title: Quality Engineer

Location – Santa Clarita/Ventura (50/50)

Reports to: Quality Assurance Manager

Compensation: 80 - 110K 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:

Administer and maintain Avita Medical Quality Management Systems (CAPA, Complaints, NCPs) and support manufacturing operations in compliance with established procedures and policies.

Key Responsibilities:

Data Analytics: Utilize data analytics tools and techniques to analyze quality data, identify trends, and provide actionable insights to improve product quality and processes.

CAPA Management: Lead and manage the CAPA process, including identifying root causes, developing corrective and preventive actions, and ensuring timely implementation and effectiveness. Coordinate tasks associated with Corrective and Preventive Action (CAPA) process including:

• Administration of CAPA system in QT9 (eQMS)
• Work cross-functionally to perform root cause analysis utilizing appropriate investigation tools
• Assure CAPA investigations are thorough and completed in a timely manner
• Administration of CAPA database
• CAPA trending and analysis

Investigation: Conduct thorough investigations of quality issues, non-conformances (NCPs), and customer complaints. Document findings, root causes, and corrective actions.

Sustaining Quality Engineering: Support ongoing quality improvement initiatives, including process validation, risk management, and compliance with regulatory requirements.

Quality Systems: Maintain and improve quality systems, including documentation, audits, and compliance with industry standards (e.g., ISO 13485, FDA QSR).

Collaboration: Work closely with cross-functional teams, including manufacturing, engineering, and regulatory affairs, to ensure quality objectives are met.

Training and Development: Provide training and support to team members on quality processes, tools, and best practices

Compliance: Support maintenance of all quality records and documentation in accordance with the quality manual and applicable procedures and regulatory requirements

Develop Quality procedures and Work Instructions for implementation of the QMS

Other responsibilities as assigned by supervisor

Knowledge/Skills:

• CAPA, Data analytics, and root cause investigation skills
• Knowledge and application of ISO 14971:2019
• Analytical and problem-solving skills
• Strong computer skills: proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Excellent written and oral communication skills
• Ability to work on multiple projects simultaneously.
• Ability to work independently and as a member of a team.
• Driven, self-starter who works effectively cross functionally.
• Familiarity with requirements related to compliance, risk and customer representative interface
• CQA/CQE certification preferred

Education/Experience

• Science, Engineering or other technical degree with minimum 3 years of experience in Medical device Quality or minimum 7 years in Medical Device Quality.
• Experienced in conducting and documenting complaints and CAPA investigations.
• 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.

Office

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.

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.