Sr. Supplier Quality Engineer

Regulatory Toolkit; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Saluda Medical, headquartered in Minneapolis, MN, seeks a Sr. Supplier Quality Engineer to lead supplier qualification, monitoring, audits, and CAPAs for external partners ensuring quality and regulatory compliance in medical devices.

You will collaborate with Quality, Supply Chain, Engineering and Manufacturing to drive supplier performance, risk reduction, and continuous improvement across the product lifecycle.

Qualifications

• BS degree in engineering or similar field.
• Minimum 5 years of quality engineering or manufacturing engineering in medical or regulated industry.
• Experience communicating with cross-functional teams and external suppliers.
• Lead auditor of quality systems (ISO 13485) experience.

Responsibilities

• Develop and maintain collaborative supplier partnerships to ensure materials, components, devices, and services meet quality, regulatory, and performance requirements.
• Serve as the quality lead for supplier-related activities including sustaining engineering projects and supplier change management.
• Establish, monitor, and analyze supplier performance metrics and drive improvement actions.
• Own supplier-related quality events, SCARs, and CAPAs with root-cause analysis and effectiveness verification.
• Plan and conduct supplier quality audits and assessments for regulatory and internal standards.

Skills

Quality engineering

Supplier management

Auditing ISO13485

Communication skills

Travel coordination

Education

BS Degree in Engineering

Job description

Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback.

Saluda Medical’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

Reporting to the Director of Quality, the Sr. Supplier Quality Engineer is responsible for ensuring external suppliers and contract manufacturers consistently deliver high-quality materials, components, finished devices, and services that meet Saluda Medical quality, regulatory, and business requirements. This role serves as a quality lead for supplier management activities and partners closely with Supply Chain, Engineering, Manufacturing, Operations, and external suppliers to drive supplier performance, continuous improvement, risk reduction, and compliance throughout the product lifecycle.

The Sr. Supplier Quality Engineer provides quality leadership for supplier qualifications, supplier monitoring, supplier changes, nonconformance investigations, corrective and preventive actions, audits, and continuous improvement initiatives to support the reliable distribution of safe and effective medical devices.

What You’ll Do:

• Develop and maintain collaborative supplier partnerships to ensure materials, components, devices, and services consistently meet Saluda quality, regulatory, and performance requirements through effective supplier qualification, onboarding, risk assessment, quality agreements, and ongoing performance management.
• Serve as the quality lead for supplier-related activities supporting sustaining engineering projects, supplier transfers, process improvements, and supplier change management, including risk assessments, validation impact reviews, and approval of supplier change requests.
• Establish, monitor, and analyze supplier performance metrics, including incoming quality, nonconformances, complaints, field performance, delivery quality, and responsiveness; drive supplier quality improvement initiatives and corrective actions when performance targets are not achieved.
• Own supplier-related quality events, including supplier-caused nonconformances, Supplier Corrective Action Requests (SCARs), and CAPAs, ensuring effective root cause analysis, corrective action implementation, and verification of effectiveness.
• Plan and conduct supplier quality system audits and assessments to ensure compliance with applicable regulatory requirements, industry standards, and Saluda quality system expectations.
• Partner with Supply Chain, Engineering, and Operations to identify, qualify, and monitor new suppliers, components, materials, and contract manufacturing partners, ensuring appropriate quality and risk controls are established.
• Support regulatory compliance and inspection readiness activities, including preparation for internal, customer, and regulatory audits related to supplier quality processes and records.
• Contribute to the development, implementation, and continuous improvement of supplier management processes, procedures, and quality system requirements while promoting a culture of quality, compliance, accountability, and continuous improvement throughout the organization and supplier network.

What You’ll Bring:

• BS Degree in Engineering or similar
• 5+ years of quality engineering or manufacturing engineering in medical industry or other regulated industry.
• Ability to communicate effectively, including scaling communication style and depth according to audience and verbal and written communication
• Ability to work independently and collaborate with internal and external project teams
• Travel up to 15% of time
• Experience in global supplier management
• Experience with manufacturing support or process development
• Lead auditor of quality systems (ISO 13485) experience
  

Our Core Values:

• People – Our first responsibility is to the patients we serve.
• Integrity – Do the right thing
• Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
• Performance – Win together – Deliver with Excellence.

Saluda Medical embraces diversity and equal opportunity. 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.

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.