Zap Surgical Systems, Inc. is a surgical robotics start-up located in San Carlos, CA. ZAP designs and manufactures the ZAP-X® Gyroscopic Radiosurgery™ platform, the world’s first and only vault-free, cobalt-free radiosurgery system.

We are seeking a Quality Assurance Lead to ensure that our products meet the highest quality standards and comply with all applicable regulations and standards. The Quality Assurance Lead will lead and manage our quality control and quality assurance processes, and work closely with cross-functional teams to establish and maintain effective quality management systems. Individual(s) will apply advanced theoretical knowledge of subject matter principles and concepts, as well as experience with risk management processes, to perform the duties of the position.

Job responsibilities and duties include:
Develop, implement, and maintain quality management systems, including policies, procedures, and documentation, to ensure compliance with relevant regulations and standards such as ISO 13485, FDA QSR, and other applicable regulations.

Lead and manage the quality control and quality assurance processes, including incoming inspection, in-process inspection, and final inspection of radiosurgery medical devices, as well as review and approval of batch records, test reports, and other quality-related documents.

Establish and maintain key performance indicators (KPIs) and metrics to monitor product quality and process performance and provide regular reports to senior management.

Conduct internal audits to ensure compliance with quality management systems and provide guidance and support to other departments on quality-related matters.

Lead investigations into quality incidents, deviations, and non-conformities, and implement effective corrective and preventive actions (CAPAs) to address root causes and prevent recurrence.

Coordinate and support external audits by regulatory agencies, customers, and other stakeholders, and ensure timely and effective responses to audit findings.

Provide training and guidance to employees on quality management systems, quality standards, and regulations, and promote a culture of quality awareness and continuous improvement throughout the organization.

Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Clinical Affairs, to ensure that quality requirements are addressed in all stages of the product lifecycle, from design and development through manufacturing and post-market surveillance.

Stay updated with changes in regulations, standards, and industry best practices related to quality management systems and medical devices, and proactively identify and address potential compliance risks.

Participate in risk management activities, such as hazard analysis, risk assessments, and FMEA, to identify and mitigate potential risks associated with product quality and safety.

This position has no supervisory duties.

Minimum requirements:
Master’s degree in Biomedical Engineering or any related Biological Science or Engineering field of study, plus at least 1 year of experience in the job offered or in any related position(s) in which the required experience was gained.

Qualified applicants must also have demonstrable proficiency, skill, experience, or knowledge with the following:

Demonstrated experience as a quality engineer in a medical device environment.
Demonstrated knowledge of ISO 13485:2016/FDA QSR quality systems and EU MDR 2017/745
Demonstrated knowledge of CAPA system, complaints, supplier quality, and process verification/validation.
Demonstrated proficiency with Microsoft Office Suite
Risk management processes, such as hazard analysis, risk assessments, and FMEA.
Demonstrated experience conducting internal audits and managing external audits by regulatory agencies and customers.

No travel required. No work from home benefit available.

Additional Information:
Job Site: 590 Taylor Way, Suite A, San Carlos, CA 94070
Salary: $134,056 per year
Send Resumes To: Attn: Robert A. Starr bob@zapsurgical.com
No calls. EOE.
Must be legally authorized to work in the United States without sponsorship.

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