Quality Assurance Manager

About Sabre Medical Pty Ltd

Since our inception in 2005, Sabre Medical has been dedicated to designing and delivering reliable and innovative packaging solutions for our customers' medical devices, specializing in crafting custom-designed packaging solutions. We boast four cutting-edge Class 7 and 8 cleanrooms on-site, equipped with the highest quality machinery, equipment, and technologies.

If you operate your own cleanrooms, we can provide both expert guidance and the highest quality consumables and alcohols. Our services include an extensive range of testing and validation, along with valuable tray sealing and pouch sealing machines.

We take pride in our ISO 13485 accreditation and are conveniently located in Lane Cove West .

Responsibilities And Duties

Perform the function of Quality Assurance Manager:

• Ensure that the Product Process requirements are effectively established and efficiently maintained; reporting on issues relating to Products and Environments.
• Coordinate the cleanroom team and resolve Process or technical issues that arise in the transfer of products from design to the cleanroom team and release by Quality.
• Train operators and interns in the standards of ISO13485 and ISO14971 (risk assessments)
• Develop processes within the team that are compliant to standards for medical devices ISO13485.
• Engage and handle appropriate Corrective and Preventive Actions (CAPA) and internal audits.
• Review and approve production qualifications and validation protocol Preparing the technical reports for new processes being setup in production.
• Assist in developing manufacturing processes and customer projects assuring compliance of operations and products to meet specifications and requirement.
• Participates in new product development/design control as needed.
• Other duties may be assigned, as required.

Qualifications

• Quality Engineer; B Chemical Engineering - Biomedical Engineering - Bachelor Science or related Science field.

Experience And Qualifications

• At least Two (2) years of Post Graduate experience in a regulated industry of Pharma or Medical Devices manufacturing environment.
• Proficient in regulations such as ISO 13485, (Medical Devices) Regulations and applicable standards such as ISO14971, ISO11135 or ISO11137.
• English with strong written and oral communication skills.
• Working knowledge of Process validation.
• Computer Literate use of statistical programs
• Capability for analytical and strategic processes.
• Team oriented skills for problem resolution and implementation of projects.
• Attention to detail, meticulous accuracy with written and numerical work.
• Problem solving - logical person.
• Strong interpersonal skills for a management role