Position Title: Supplier Quality Engineer

Location – Valencia

Report to: Manager, Quality Compliance

Compensation: 80 - 110K plus annual bonus

AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies optimize wound healing, effectively accelerating the time to patient recovery.

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 :

Ensure that all products, services and materials received from external suppliers meet the company's quality standards by actively managing supplier relationships, conducting quality audits, and implementing improvement strategies to maintain consistent quality throughout the supply chain. Follow established procedures and policies for the selection, qualification, and evaluation of suppliers to meet the requirements of purchasing controls in a regulated medical device company.

Key Responsibilities :

• Collaborate with Product Development, Supply Chain, and Operations in selection and evaluation of new suppliers and second sourcing activities
• Conducts supplier audits, (onsite or virtual) based on business needs
• Identification of continuous improvement opportunities and streamline processes
• Drive corrective actions/supplier corrective action requests (SCAR) within suppliers’ management process
• Effectively addresses supplier quality issue by leading investigation at the supplier to ensure the appropriate corrective action is implemented
• Management of critical suppliers for changes (supplier change notifications), and effectively assess the impact of the changes to AVITA product, conducts qualification due to the changes (if needed), and communication of the change
• Demonstrate knowledge of requirements and standards such as 21 CFR 820, ISO 14971, ISO 13485, ISO 9001, and others as applicable
• Maintain Approved Supplier List (ASL) and supplier records in QT9, AVITA’s electronic Quality Management System (eQMS), including surveys, certifications, performance evaluations, audit schedules, reports, and quality agreements
• Work with cross functional groups including Document Control, Purchasing, PMO, R&D, Quality Engineers, Manufacturing Engineers, Legal, and Regulatory
• Participates in the AVITA Internal audit program
• Travel required to supplier sites (25%)
• Other duties as assigned by Manager

Job Requirements:

• Prefer Bachelor of Science or equivalent with at least 5+ years of work experience in engineering, quality assurance and/or supplier quality within FDA QSR/ISO regulated industry.
• Sterilization experience a plus
• Lead auditor or ASQ CQA certification a plus
• Experience working in the medical device or pharmaceutical industry
• Experience working with outsourced contract manufacturing (CMO)
• Experience with Process Validations (i.e., IQ, OQ, PQ)
• Proven success in the management of suppliers and auditing
• Demonstrated abilities and knowledge in electronic document change management, revision control, and validation
• Experience working in the medical device or pharmaceutical industry
• Experience working with outsourced contract manufacturing (CMO)
• Experience with Process Validations (i.e., IQ, OQ, PQ)
• Proven success in the management of suppliers and auditing
• Demonstrated abilities and knowledge in electronic document change management, revision control, and validation
• Knowledge of inspection/measurement methods and technology

EEOC: 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 needs.

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 accommodation 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 is 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.

Information Security Compliance

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.