Senior Supplier Quality Engineer

Pay Rate: Up to $77.00 per hour or about $157,000 a year

Job Type: Long Term Contract to Perm

Work Authorization:

Applicants must be authorized to work in the U.S. without current or future visa sponsorship. The client is unable to consider candidates requiring sponsorship.

Position Overview

As a Senior Supplier Engineer, you will serve as the technical bridge between Cardiac Diagnostics (CDx) design teams and the global supply chain. You will play a critical role in integrating new and existing technologies into CDx products, directly impacting the reliability, scalability, and speed at which life-changing devices reach patients.

In this role, you will collaborate with R&D, Quality, Operations, and Regulatory teams to integrate OEM and subsystem supplier designs and components into CDx products, ensuring compliance with performance and safety requirements. The scope includes supplier design assurance, supplier product development integration, and third-party manufacturing assurance.

This position follows a hybrid work model requiring onsite presence at least three days per week to support supplier engagement, design assurance activities, and cross-functional collaboration.

Key Responsibilities

• Collaborate with medical device OEMs, subsystem, and component suppliers to define supplier specifications and successfully integrate supplied designs and components into CDx development and manufacturing processes.
• Partner with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project Management to execute supplier control deliverables, including:
• Purchased material qualifications
• Supplier-driven change assessments
• Supplier design and capability improvement initiatives
• Regulated compliance assessments
• Generate and review quality plans, quality agreements, product specifications, component qualifications, design verification and validation documentation, and process validations.
• Investigate complaints and manage supplier investigations related to both design and manufacturing issues.
• Participate in supplier audits to assess compliance with regulatory standards and CDx specifications, including:
• Evaluation of audit observations and findings
• Reporting and documentation
• Follow-up and verification of corrective actions
• Serve as a technical expert to ensure repeatable and reproducible product quality and reliability throughout the product lifecycle.
• Evaluate new and existing suppliers and technologies for future product integration or quality and reliability improvements.
• Participate in risk assessments related to supplier capabilities, designs, and supply processes, including development of risk mitigation strategies to ensure continuity of supply.
• Coordinate all phases of supplier engineering activities, communicate emerging risks, and present recovery plans to site leadership and stakeholders.
• Demonstrate a strong commitment to patient safety and product quality by ensuring compliance with the Quality Policy and all documented quality systems and procedures.

Required Qualifications

• Bachelor’s degree in Engineering or a related discipline
• Minimum 5 years of technical experience in medical device development
• Experience with:
• Design controls
• Process validation
• CAPA
• Ability to travel 5–10% globally (approximately 5–10 trips per year, including Sweden, China, Finland, and domestic travel)

Preferred Qualifications

• 7+ years of medical device development experience with design assurance focus
• Experience working with suppliers and applying design and supplier controls per 21 CFR 820 and MDR
• Quality systems auditing experience (ISO 13485 or similar)
• Strong data analytics and critical thinking skills
• Project management experience in cross-functional environments
• Highly organized and detail-oriented with the ability to manage multiple priorities
• Strong interpersonal and communication skills with the ability to build internal and external partnerships