Saluda Medical is a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry through the development and commercialisation of data-driven, personalised therapies and advancing neuromodulation systems for the next generation of implantable stimulation devices. Reporting to the Director of Quality, the Supplier Quality Engineer is responsible for the management of suppliers who provide components and finished medical devices to Saluda Medical, supporting quality processes such as nonconformances, complaint handling, and CAPAs.

Accountabilities and Associated Responsibilities:

This primary responsibility for this role is to ensure that Saluda continues to deliver high quality devices for our patients through managing suppliers of finished devices, parts, materials, and services, and supporting the processes which confirm device quality. The Supplier Quality Engineer will have the following specific responsibilities:

• Partner with suppliers to ensure that supplied items are of high quality and meet Saluda Medical requirements, including internal collaboration for resolution of supplier-related challenges.
• Lead the process to assess and approve supplier change requests by engaging the supplier and Saluda cross-functional peers, including supply chain, sustaining engineering, and regulatory.
• Monitor product performance in the field by supporting the complaint handling process through evaluation of customer complaints, returned products and complaint trending.
• Support the nonconformance and CAPA processes by leading or assisting in investigations, implementation of actions, and product disposition.
• Conduct supplier quality system audits on a recurring basis to ensure suppliers quality systems meet Saluda Medical quality standards.
• Tracks and trend supplier-related data from receiving inspection and manufacturing to assess overall supplier performance and ensure corrective actions are taken in a timely manner when needed.
• Work with product engineering and supply chain in the selection and qualification of new suppliers, components, and finished devices.
• Develop and maintain Receiving Inspection requirements and associated test methods, as needed.

Essential Requirements:

• Bachelor’s degree in Engineering (Mechanical, Electrical or Biomedical) or Life Sciences
• 2 years of quality assurance experience in medical industry or other regulated industry.

Desirable Requirements:

• Proven ability to maintain professional and respectful relationships with co-workers in high impact situations
• Strong relationship builder and communicator with a high desire to learn and grow as a quality engineering professional.
• PC Skills, MS Office, and the ability to generate and interpret trend charts

Saluda Medical embraces diversity and equal opportunity in a serious manner. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation. The more inclusive we are, the better our work will be.

Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.