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Senior Quality Engineer

1 month ago

San Jose, United States Lumicity Full time

Job Title: Senior Quality Engineer- Competitive Salary / San Jose, California Position Overview: We are seeking a highly skilled and experienced Senior Quality Engineer with a strong background in catheter technology to join our team. The ideal candidate will play a critical role in ensuring the highest standards of quality and compliance for our catheter products throughout their lifecycle. This position requires a proactive and detail-oriented professional who can lead quality initiatives and collaborate effectively with cross-functional teams. Key Responsibilities: Quality Assurance and Control:

Develop, implement, and maintain quality assurance and control processes specific to catheter products, ensuring compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820). Design and Development:

Collaborate with R&D and engineering teams to ensure quality is built into the design and development process of catheter products, from concept through commercialization. Risk Management:

Conduct risk assessments and develop risk mitigation strategies for catheter products, utilizing tools such as FMEA and fault tree analysis. Process Validation:

Lead process validation activities, including IQ/OQ/PQ, for catheter manufacturing processes to ensure consistent product quality and compliance. Supplier Quality Management:

Manage and evaluate suppliers and contract manufacturers to ensure they meet quality standards for catheter components and assemblies. Non-Conformance Management:

Investigate and resolve non-conformances, root cause analysis, and implement corrective and preventive actions (CAPA) to address quality issues. Audits and Inspections:

Prepare for and participate in internal and external audits, including regulatory inspections, to ensure ongoing compliance with quality standards. Documentation and Reporting:

Maintain accurate and comprehensive quality documentation, including quality plans, inspection reports, and regulatory submissions. Qualifications: Bachelor’s degree in Engineering or a related field. Minimum of 5-7 years of experience in quality engineering within the medical device industry, with a focus on catheter products. Strong understanding of catheter design and manufacturing processes, quality systems and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and other relevant standards. Certification in Quality Engineering (CQE) or related certification is a plus. Interviews taking place imminently, for consideration please apply.

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