Senior Quality Engineer - Neurolutions, Inc.

About Us:

We are a cutting-edge medical device start-up dedicated to restoring upper extremity function for stroke patients. As we scale our manufacturing operations, we are seeking a highly skilled Senior Quality Engineer to join our team and ensure the highest standards of quality and compliance.

Position Overview:

The Senior Quality Engineer will play a critical role in our organization by managing the complaint handling and material review board processes, providing technical leadership for device failure investigations, enhancing inspection and test methods, and participating in audits of suppliers and internal operations. This position is essential to our mission of delivering safe and effective medical devices to our customers.

Key Responsibilities:

1. Complaint Handling and Material Review Board (MRB) Process:

   - Manage the complaint handling process, ensuring thorough investigation, root cause analysis, and timely closure of issues.

   - Lead the 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.

2. 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.

3. 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.

4. 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.

Qualifications:

- 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.

This is a full time role with a minimum 32 hrs per week onsite at the Van Nuys facility

Why Join Us:

- Opportunity to make a meaningful impact on patients’ lives.

- Collaborative and innovative work environment.

- Competitive salary and benefits package.

- Professional growth and development opportunities.

Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.

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