Quality Control Inspector

1 week ago

Macquarie Park, Australia Saluda Medical Full time

**About Saluda Medical
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.

**What We’re Looking For...
As a Quality Control Inspector, you will be responsible for Good Inward Inspection, completing product Inspection, conducting Final Product DHR Review for an implantable medical device. This role supports the implementation and management of quality controls, quality improvement projects, and production related quality issue investigations.

Ensuring compliance within the manufacturing processes by partnering with Manufacturing Managers and Engineers and other necessary stakeholders across the core functional teams and other business partners.

**Please note that this is a 6-month fixed term contract.
**Your role will include:
- 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 and support investigation and disposition of non-conformance reports.
- External laboratory sample management as 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.

**About you:
- 3 years’ experience in quality within the medical device industry
- High attention to detail
- Have the drive, passion, and ability to execute and maintain quality systems in addition to understanding statistical analysis techniques and strategies.
- 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.

**It’s not essential, but nice if you have:
- LEAN manufacturing training
- Experience in process validation
- 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.

**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 and contribute to making an impact on patient care, then this is the opportunity for you Please **APPLY NOW

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