Quality Control Inspector

600 – Quality       ·       Macquarie Park, New South Wales      ·       Full time

We are looking for a Quality Control Inspector to perform quality control processes in our office in Macquarie Park.

About Saluda 

Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord’s response to stimulation and make real-time adjustments to therapy. We are a cutting edge, progressive Australian based Medical Device company with offices and employees based in Europe, Australia, and the U.S We are at the forefront of spinal cord stimulation technologies for the management of chronic pain.

Our team is made up of world-class engineers, clinicians, and seasoned professionals with experience in bringing medical technologies to life.

What we’re looking for

As our experienced Quality Control Inspector, you are driven by a passion to assist and support the team in conducting Quality Control Inspections- receiving, in process, and final – for an implantable medical device.

 Accountabilities and Associated Responsibilities:

• Inspecting incoming, in process, and finished goods
• Ensure that quality is implemented and adhered in handling components and products
• Review product testing results and report non-conforming issues
• Maintain adequate records of inspections and testing
• Initiate non-conformance reports
• Participate in non-conformance investigation and actions to resolve when required
• Comply with applicable regulatory requirements including FDA’s Quality System Regulation, European Medical Device directives, and TGA regulations
• Performs duties in compliance with Saluda Medical’s Management System, comprising the company policies regarding the Quality Management System, health, safety, and environmental compliance
• Participate in internal audits to ensure the company’s quality system is effective.
• External laboratory sample management as required.

About you

• You are someone who has high attention to detail with at least 5 years of experience in quality within the medical device industry.
• Have the drive, passion, and ability to execute and maintain quality systems in addition to understanding statistical analysis techniques and strategies.
• You are confident in building relationships and communicating across diverse work teams.

Desirable Requirements, nice if you have:

• LEAN manufacturing training
• Experience in process validation
• Product lifecycle management system development
• Understanding of the requirements of ISO 13485:2016 and/or 21CFR 820
• Pragmatic ability to produce top quality work under tight deadlines, and to find practical and innovative solutions to complex and ambiguous problems.
• Excellent communication and organisation skills that are effective in driving outcomes with diverse international stakeholders
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Passion for technological innovation, helping patients, and building lasting relationships with end customers.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt.

Are you Ready to Join? If you would like to be part of our team developing the world’s next generation of implantable device technology, enjoy working with complex systems, and working through challenges knowing your indirectly contributing to making an impact to patient care then this is the opportunity for you! Please APPLY NOW!

Applications will only be considered from candidates who have the appropriate approval to work in Australia, no visa or sponsorship support is available for this role. 

Saluda Medical is an equal opportunities employer. We are committed to building a team that value the variety of unique experiences , qualities, characteristics, and skills.  We believe people are the source of our inspiration and innovation , sharing and learning from each other embracing a diverse and inclusive work environment.

Saluda Medical is a class 3 medical device company; we support the health of our patients, our vendors and our employees. Therefore, we request that all those joining our team are fully vaccinated against Covid-19. Please do let us know if you would have any concerns around providing us with a record of your current vaccination status should you be successful in this role.

All eligible candidates are invited to apply; We respectfully ask for no agency approaches

Please click here to apply.