Quality Assurance Document Control Specialist - España - Avita Medical Ltd

Descripción

Quality Assurance Document Control Specialist – Valencia Quality Assurance Document Control Specialist – Valencia Position overview

Coordinates, implements, and maintains Avita Medical's Document Control and Training System. Coordinates documentation activities through change management. Follows established procedures and policies to meet the demands of document control in a regulated medical device company.

Duties/Responsibilities

• Responsible for overall coordination of Document Control function within the company.
• Coordinates change control activities.
• Orders, maintains, and tracks external standards.
• Supports user requests for documentation.
• Supports change management of labeling.
• Supports Quality System training and maintains training records.
• Supports corrective action activities as CAPA Coordinator.
• Responsible for coordinating engineering change orders (ECO), facilitates review, approval, and retention of documentation.
• Maintains product complaint process as Complaints Coordinator.
• Other duties as deemed necessary by supervisor.

special knowledge / skill

• Proficient in communication and working with teams that consist of diverse personnel and scattered locations.
• Advanced English skills: writing, grammar, proofreading, redlining.
• Advanced computer skills: data entry/typing, Word, Excel, Visio, Flowcharts, other Microsoft Office software.
• Technical experience and knowledge in developing and coordinating documentation systems.
• Full understanding of documentation control systems within a medical device company certified to ISO Standards and FDA QSR

Experience

• Proven success in working with and improving medical device quality systems. Knowledge of both FDA QSR and ISO standards. Demonstrated abilities and knowledge in document change management.

Education / Experience:

• Prefer Bachelor of Science or equivalent with 3-5 years' experience in documentation control systems, with preference in coordination and administration of systems within a FDA QSR/ISO.

Position Location 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.

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