Quality Systems Specialist

Position:

Quality Systems Specialist - 12 Month Fixed Term Contract

Manager:

Director, Operations Quality and Quality Systems

Location:

Macquarie Park, Australia

Position Profile:

Saluda Medical was founded in 2013 for the purpose of transforming patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain management results and, with more than 10 years of advanced research development and clinical experience, we design and develop advanced neuromodulation systems for the next generation of implantable stimulation devices.

Reporting to the Director, Operations Quality and Quality Systems, the Quality Systems Specialist is responsible for maintaining the company’s quality management system.  

Please note that this is a 12 month Fixed Term role. 

Accountabilities and Associated Responsibilities:

• Develop and maintain the quality management system across all aspects of the company to assure compliance to ISO 13485:2016 and all applicable international standards and regulations.
• Manage the internal audit program.
• Conduct internal audits to assure Saluda products quality systems.
• Internal coordinator for all audits and inspections of regulatory and quality nature, including unannounced audits.

• Manage the change control process.
• Manage the CAPA process.
• Processing changes made through the change control processes.

• Support development and validation of any quality management related software.
• Ensure an effective training program is implemented and maintained.
• Administer the quality planning process.
• Administer the management review process.
• Other duties as directed by the Manager.

Essential Requirements:

• Tertiary qualifications in engineering or science
• At least 3 years of professional experience in a quality function in a medical device or pharmaceutical company.
• Proven ability to execute and implement / maintain quality systems.
• Strong relationship builder and communicator with experience in diverse work teams.
• Demonstrates integrity and reliability, strives for excellence in her/his work.

Desirable Requirements:

• Implantable/active implantable medical device experience.
• Document management experience
• Internal audit training and experience