Supplier Quality Engineer - Medical Devices - Remote

Job DescriptionJob Description

Job Title: Supplier Quality Engineer – Medical Devices

Location: Remote
Duration: 1 year +

Job Summary:

We are seeking a Supplier Quality Engineer (SQE) with experience in the medical device industry to support supplier quality processes and ensure compliance with regulatory and quality standards. The SQE will be responsible for supplier audits, qualification, performance monitoring, and corrective actions to ensure components and materials meet required specifications and standards (FDA, ISO 13485, etc.).

Key Responsibilities:

· Develop and maintain supplier quality systems in compliance with ISO 13485, FDA 21 CFR, and internal quality standards.

· Perform supplier audits, assessments, and qualifications.

· Lead supplier non-conformance investigations and Corrective and Preventive Actions (CAPA).

· Work closely with R&D, manufacturing, and procurement to qualify new suppliers and materials.

· Review and approve supplier process validations and quality documentation (PPAP, FAI, etc.).

· Monitor and report supplier performance metrics (quality, delivery, service).

· Conduct risk assessments and support supplier change control.

· Develop and maintain incoming inspection and sampling plans.

· Ensure timely resolution of supplier-related quality issues.

· Participate in internal and external audits as needed.

Qualifications:

· Bachelor’s degree in Engineering, Life Sciences, or related technical field.

· 5+ years of experience in supplier quality engineering in the medical device industry.

· Strong knowledge of ISO 13485, FDA QSR (21 CFR ), and GMP requirements.

· Experience with supplier audits, CAPA processes.

· Familiar with tools such as FMEA, Root Cause Analysis, etc.

· Proficient in MS Office and quality tools (e.g., Minitab, QMS software, etc).

Soft Skills:

· Strong interpersonal and communication skills.

· Ability to manage multiple priorities and work cross-functionally.

· Detail-oriented with strong analytical and problem-solving skills.