Senior QC Inspector
This position will perform inspection and measurement of purchased materials and products in accordance with specified requirements and conforming to cGMP/QSR (21 CFR 820) and ISO 13485 quality systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform essential inspection and measurement of incoming materials and products including First Article Inspection of mechanical (sheet metal, machined, molded), cable, and electrical products, using applicable measurement and inspection tools.
- Document and report inspection results as appropriately per documented procedures.
- Document and report of nonconformance using Nonconforming Material Report.
- Participate in material review board (MRB) meeting to review material nonconformance.
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Mastered the use of quality control disciplines, tools, sampling inspection plan, and analyzing methodologies.
- Good understanding and experience with GD&T standard (ASME Y14.5M-2009)
- Must have good communication and time management skills.
- Working experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements are required. Must also have working knowledge and experience in the following areas: Quality Control, Materials Control, Non-Conforming, CAPA, Sterilization, and general Quality Systems compliance.
- Preferred experience with IPC-A-610 F Acceptability of Electronic Assemblies and inspection of electro-mechanical systems.
EDUCATION and/or EXPERIENCE:
- This position requires 5+ yrs. in mechanical inspection and measurement of complex parts and experience working in a regulated medical device industry.
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ Nano-Pulse Stimulation™ (NPS™) platform. The Company’s CellFX NPS platform provides a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane initiating a cascade of events within the cell that results in regulated cell death. The novel characteristics of the Company’s NPS mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.
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.