What are the responsibilities and job description for the Senior Quality Engineer position at Lumicity?
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.
