Staff Quality Engineer, Laza Medical

Laza Medical, a Shifamed Portfolio Company, is at the forefront of developing state-of-the-art imaging solutions for cardiovascular applications. Our mission is to democratize top-quality cardiovascular imaging using robotics and AI. To learn more about Laza Medical, please visit https://lazamedical.com/.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

The Staff Quality Engineer will be responsible for the development and execution of quality management system (QMS) and quality engineering activities at Laza Medical. This individual will work proactively with cross functional team members on the development of product requirements, verification, and validation strategies. This position represents an exciting opportunity to join an innovative and high performing team and influence design and development in early stages. This is a full time on-site position and will require reporting to our offices located in Campbell, CA.

Responsibilities, Skills & Hands-On Experience

• Lead the development of QMS infrastructure and processes per FDA Quality Management System Regulations (QMSR) and ISO 13485 and ensure the compliance to these processes.

• Drive design controls deliverables, including but not limited to Design History File (DHF), design verification documentation and risk management documentation.

• Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.

• Review design control documentation, including but not limited to, requirements, specifications, test methods, protocols, and reports.

• Develop quality inspection methods and processes for design and manufacturing.

• Qualify and maintain suppliers per the supplier management process.

• Provide guidance and maintain compliance to applicable standards, and regulations (such as ISO 13485, ISO 14971, IEC 60601-1, ISO 10993-1, and FDA QMSR)

• Establish, implement and monitor training related to QMS processes, documentation and record control.

• Participate in both internal and external regulatory audits and inspections.

• Report to appointed management representative on the effectiveness of the quality management system and any need for improvement.

Education & Work Experience

• Bachelor's degree in Engineering, Science or Technical Field with a minimum of 7+ years of experience in Engineering and/or Quality.

• Experience with ISO 13485 certification, quality engineering, supplier quality engineering, and software quality engineering activities for new product development.

• Ability to author technical reports, and standard operating procedures.

• Strong communication and team management skills.

• Demonstrated ability to support multiple projects.

• Exposure to medical robotics is a plus.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.