Sr. Quality Assurance Manager

POSITION SUMMARY:

This position will be responsible for all activities related to quality system development, implementation, and maintenance of 21 CFR Part 820 and Part 11 QSR compliance matters for all Pulse Biosciences products and its manufacturing facility. In addition, this position will support the development and implementation of ISO 13485: 2016, EU MDR regulatory requirements, applicable international quality systems and overall compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

QUALIFICATIONS:

This position requires 10+ years in quality system development, implementation and compliance experience in the medical device industry with at least 5 years management responsibility and a Bachelor’s degree in Engineering, Technology, Business, or other life science degree. Demonstrated ability to successfully work with individuals and cross-functional team environment. Strong ability to influence and work with personnel at all levels. Good organization, interpersonal, negotiation, time/project management, motivational, and judgment skills. Demonstrated ability to effectively support facility inspections conducted by Regulatory Agencies. PC proficient (e.g., Windows, Word, Excel, PowerPoint). Must also have in-depth working knowledge and experience in the following areas: Design Control, Design V&V and Process Validation, Risk Management, UDI implementation, Complaint handling, eMDR/Vigilance Reporting, CAPA management, etc.

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.

CONTACT:

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.