Director, Operations Quality

at  Saluda Medical

Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence. Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.
At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.
The Director, Operations Quality reports to the SVP, Global Quality and Supplier Engineering and is responsible for managing the company’s quality activities at the Saluda Medical manufacturing and distribution facility in Macquarie Park.

Accountabilities and Associated Responsibilities:

• Manage quality control (QC) activities, to include receiving inspection and final inspection and product release.
• Manage quality assurance activities in the manufacturing and distribution facility, to include non-conformance reports (NCR) and component and raw material supplier management.
• Ensure activities performed in the facility are compliant to global regulatory requirements for which we claim compliance, as well as Saluda business expectations.
• In partnership with the Head of Manufacturing Operations and Head of Manufacturing Engineering, be a vocal advocate for a strong culture of quality and compliance.
• Build strong working relationships with manufacturing operations leadership, product development and other quality assurance peers.
• Overall responsibility to ensure products distributed from the facility are of high quality and in compliance with the requirements of 21 CFR 820, ISO 13485, the European Medical Device Directors/Medical Device Regulation, and other international quality system regulations and standards as appropriate.
• Provide leadership to both inspectors and quality engineers utilizing an inclusive and empowering leadership approach.
• In partnership with manufacturing operations, ensure the voice of manufacturing quality is an input to the design and development of new products.
• Manage quality related design transfer activities
• Approve engineering changes to maintain DMR/DHR for all products manufactured in Australia
• Develop and ensure the implementation of Manufacturing Quality Plans
• Provide input into DMR/review/approve
• Ensure prompt investigation and action, and escalate production quality issues based on appropriate analysis
• Participate in internal and external audits to ensure company’s quality system is effective
• Manage and lead quality improvement projects in all areas of responsibility.

Essential Requirements:

• University degree qualified in an engineering discipline
• At least 10+ years of experience in quality/manufacturing in medical device companies
• Proven ability to execute and maintain quality systems.
• Strong relationship builder and communicator with diverse work teams

Desirable Requirements:

• LEAN manufacturing training
• Experienced in process validation
• Product lifecycle management system development

• Manage quality control (QC) activities, to include receiving inspection and final inspection and product release.
• Manage quality assurance activities in the manufacturing and distribution facility, to include non-conformance reports (NCR) and component and raw material supplier management.
• Ensure activities performed in the facility are compliant to global regulatory requirements for which we claim compliance, as well as Saluda business expectations.
• In partnership with the Head of Manufacturing Operations and Head of Manufacturing Engineering, be a vocal advocate for a strong culture of quality and compliance.
• Build strong working relationships with manufacturing operations leadership, product development and other quality assurance peers.
• Overall responsibility to ensure products distributed from the facility are of high quality and in compliance with the requirements of 21 CFR 820, ISO 13485, the European Medical Device Directors/Medical Device Regulation, and other international quality system regulations and standards as appropriate.
• Provide leadership to both inspectors and quality engineers utilizing an inclusive and empowering leadership approach.
• In partnership with manufacturing operations, ensure the voice of manufacturing quality is an input to the design and development of new products.
• Manage quality related design transfer activities
• Approve engineering changes to maintain DMR/DHR for all products manufactured in Australia
• Develop and ensure the implementation of Manufacturing Quality Plans
• Provide input into DMR/review/approve
• Ensure prompt investigation and action, and escalate production quality issues based on appropriate analysis
• Participate in internal and external audits to ensure company’s quality system is effective
• Manage and lead quality improvement projects in all areas of responsibility