Sr Supplier Quality Engineer

About the role

As a senior quality professional, this role provides Quality Engineering support (may focus on product or supplier quality) across the development, manufacture, and distribution of Imperative Care’s medical device products. This position applies Quality Engineering principles to ensure compliance with applicable regulations (FDA, ISO 13485) and internal Quality System requirements, while driving continuous improvement across either product or supplier performance.

Responsibilities

• 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.

Requirements

• 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

Qualifications

• Must have a valid driver’s license and reliable transportation.
• Must be able to lift up to 25 pounds.

Skills

• Strong problem-solving and analytical skills.
• Ability to work independently and as part of a team.
• Excellent organizational and prioritization skills.
• Proficiency in Microsoft Office Suite.

Benefits

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Pay

Salary Range: $120,000 -151,000

Schedule

This position is full time.