Supplier Quality Engineer

We are seeking a Supplier Quality Engineer II to support the design and development teams in qualifying critical materials and suppliers for the launch of innovative, life‑saving medical devices. The ideal candidate will ensure compliance with internal procedures and external regulatory standards while working in a fast‑paced, collaborative environment. This role will closely collaborate with R&D, Operations, Quality, Sourcing, and Regulatory Affairs (RA) teams to ensure supplier quality and product reliability.

• Ensure compliance with all federal, state, local, and company quality regulations and policies
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• Collaborate with suppliers to ensure quality system requirements and product specifications are understood and met.
• Define and support supplier qualification requirements for OEM and custom materials and components.
• Ensure supplier validation methods and incoming quality control processes align with device risk, internal standards, and global regulatory requirements.
• Support Design Development File (DDF) documentation related to supplied components, assemblies, devices, and services.
• Participate in risk management and supplier validation activities
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• Develop and implement inspection procedures and methods for receiving inspection and supplier final release.
• Execute test method validation activities.
• Support Non‑Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) processes.
• Investigate non‑conformances and lead Supplier Corrective Action Requests (SCAR) closure
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• Bachelor’s degree in Engineering or a related scientific field.
• Minimum 2 years of experience in supplier quality, manufacturing quality, or quality engineering.
• Experience working in a highly regulated industry
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• Experience in Supplier Quality Engineering
  , including supplier/vendor audits
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• Knowledge of design controls, risk management, and test method validation
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• Hands‑on experience with quality tools such as:
• dFMEA
• Gage R&R
• Statistical quality methods
• Experience with Class II or Class III medical devices
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• Background in medical devices, pharmaceutical, biotech, or other regulated industries
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• Ability to read and interpret engineering drawings
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• Knowledge of FDA regulations and international medical device standards
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• Strong project management and organizational skills with the ability to handle multiple priorities.
• Excellent communication, documentation, and problem‑solving skills
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