• Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes.
• Lead supplier qualification, audits, requalification, and supplier quality agreement activities.
• Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts.
• Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.
• Monitor supplier performance metrics, identify risks, and drive improvement actions.
• Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness.
• Support and/or lead supplier-related CAPAs, NCRs/NCMRs, and investigations.
• Conduct deep failure analysis on supplier components and drive root cause and corrective actions.
• Implement and manage supplier change control processes, including impact assessment and approvals.
• Lead component and supplier qualification and change projects.

• Bachelor’s degree in business engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.
• Advanced degree and experience with catheters, endovascular/neurological devices is highly desired
• Experience in medical devices (catheters, endovascular, or neurological) preferred.
• Experience in both product and supplier quality engineering strongly preferred.
• Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc)
• Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices
• Excellent communication skills (both written and verbal)
• Proven ability to provide thorough and meticulous review of documents
• Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.