Job Title: Supplier Quality Engineer

Location: San Diego, CA (On-site)

Job Type: Permanent, Full Time

An innovative medical device start-up located in San Diego, developing next-generation Class II active medical devices aimed at improving patient outcomes and quality of life are seeking an experienced Supplier Quality Engineer. They are moving rapidly from development to commercialization for which the SQE will help build and maintain a robust supplier quality and documentation framework aligned with FDA and ISO standards. You will be responsible for managing supplier qualification, performance, and compliance activities to ensure the quality of materials and components. This role will also support document control processes and technical documentation critical to maintaining regulatory compliance and supporting product lifecycle management. The ideal candidate will have experience in a fast-paced start-up environment, with a strong background in quality systems, supplier quality management, and technical documentation.

Responsibilities:

• Develop and implement supplier quality processes including qualification, audits, risk assessments, and performance monitoring.
• Establish and maintain quality agreements and technical requirements with critical suppliers
• Conduct internal investigation through non-conformance and CAPA processes
• Support the team with supplier evaluation and approvals
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to define and communicate quality and documentation requirements
• Generate and monitor appropriate key performance indicators to assess supplier performance in a timely manner and drive the resolution of corrective actions from the suppliers
• Build and develop relationships with customers and suppliers to meet the demands of the business
• Demonstrate technical knowledge and principles related to medical devices in line with ISO 13485, ISO 9001, GMP Parts 201 and 211, and EU MDR.
• Exhibit a strong dedication to quality and customer service, aligned with the specific needs of the customers

Requirements:

• Bachelor’s degree within an engineering disciple or equivalent
• Minimum 3 years’ experience working within quality at a medical device manufacture
• Proven experience within Supplier Quality
• Expert knowledge GMP, 21 CFR 820, ISO13485, 14971
• Lead ISO13485 certification is highly desirable
• Experience with Class II active medical devices is strongly preferred.
• Ability to travel as required

Please reach out to [email protected] for further details.