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:
- Develop, establish and maintain quality policy, quality system procedure and practices that meet Pulse Biosciences’ customer and regulatory requirements.
- Develop, improve, modify, and establish key quality system elements to bring the current state of QSR into harmonization with the current ISO 13485: 2016 QMS implementation and prepare for future registration with a Notified Body.
- Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance.
- Proactively investigate, identify and implement best-in-class quality system compliant practices.
- Oversee change controls and manage PLM system, including issuing part numbers, part change control systems, routing of documentation for approval, and maintaining the integrity of the system.
- Develop and validate measurement methods, monitor design control standards, facilitate and perform internal audits, supplier audits and generate audit reports to support findings and/or assessment.
- Conduct routine management review.
- Assist with preparation of regulatory submissions.
- Manage training program and ensure compliance at all level.
- Act as Deputy Management Representative and as a liaison with and an escort to the Notified Body audit and Regulatory Agency inspection.
- Oversee and monitor Pulse Biosciences Non-conforming (NCR) and Corrective Action (CAPA) compliance activities. Ensure that NCMR and CAPA are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
- Develop and manage of product labeling, UDI compliance, translation, and investigator brochures for commercial and clinical studies.
- Supervise employees as assigned.
- Serve as Quality representative to provide awareness, visibility and communication on quality initiatives to support departmental and corporate quality goals and priorities.
- Drive continuous system, process, and product improvements throughout the organization.
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
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.
- Good communication skills in both verbal and non-verbal
- Have good understanding and proving practices within both FDA QSR and EU MDR/CE Marking/ISO 13485 regulations.
- Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)
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.
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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.