Medical Device Quality Assurance Specialist
7 days ago
We are seeking a seasoned Senior Quality Engineer to join our team at Neurolutions, Inc. in Van Nuys.
This full-time role involves ensuring the highest standards of quality and compliance as we scale our manufacturing operations.
Key Responsibilities- Complaint Handling and Material Review Board (MRB) Process:
- Manage complaint handling process, conducting thorough investigations, root cause analysis, and timely issue closure.
- Lead MRB process, ensuring proper documentation, disposition, and corrective actions for non-conforming materials and products.
- Collaborate with cross-functional teams to resolve quality issues and implement preventive measures.
- Technical Leadership for Failure Investigations:
- Provide hands-on technical leadership for device failure investigations, utilizing a systematic approach to identify root causes.
- Develop and implement corrective and preventive actions (CAPA) to address device failures and improve product reliability.
- Prepare detailed investigation reports and communicate findings to internal and external stakeholders.
- Inspection and Test Method Enhancement:
- Partner with the manufacturing team to enhance inspection and test methods used throughout the production process.
- Identify opportunities for process improvements and implement best practices to ensure product quality.
- Develop and validate new inspection and test protocols to support increased manufacturing volume.
- Audits and Supplier Management:
- Participate in and lead audits of potential suppliers to assess their quality systems, capabilities, and compliance with regulatory requirements.
- Conduct internal audits to ensure adherence to company policies, procedures, and regulatory standards.
- Work closely with suppliers to resolve quality issues and ensure the consistent supply of high-quality materials and components.
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- Minimum of 10 years of experience in quality engineering, in the medical device industry.
- Strong knowledge of quality management systems (QMS) and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
- Proven experience with complaint handling, root cause analysis, and CAPA processes.
- Hands-on experience with failure analysis techniques and tools.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to lead and influence cross-functional teams.
- Certification in quality engineering (e.g., CQE, Six Sigma) is a plus.
- Competitive salary: $140,000 - $160,000 per year, depending on experience.
- Benefits package includes medical, dental, and vision insurance, 401(k) matching, and paid time off.
- Opportunity to make a meaningful impact on patients' lives through the development of innovative medical devices.
- Collaborative and innovative work environment.
- Professional growth and development opportunities.
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