This position will participate in the implementation and maintaining of cGMP/QSR (21 CFR 820) and ISO 13485 quality systems, quality and materials control activities of PulseTx System, DermaPulseTx System, single-use Applicators and reusable medical devices in support of the Company’s research and development, quality, manufacturing, regulatory, and clinical efforts. In addition, this position will support the development and implementation of medical device Class II, III quality systems and compliance activities.
- Develop, establish and maintain quality/materials control methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
- Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for clinical and/or commercial distribution.
- Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection/testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
- Conducts routine and non-routine analysis, including but not limited to electro-mechanical analysis of raw materials, in-process items and finished product according to established operating procedures. Compiles data for documentation of test procedures that may include stability program testing and reliability studies
- Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
- Develop inspection methods, monitor materials processing at various stages for full traceability.
- Perform statistical and sampling plan receiving and in-process inspection and participate in MRB as appropriate.
- Manage equipment calibration/preventive maintenance tracking system and processes.
- Development of standard operating procedures, and training in the areas of quality and materials controls.
- Supervise and monitor Pulse Biosciences Non-conforming (NCMR) compliance activities. Ensure that NCMR’s are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
- Support management review activities, internal audits, Notified Body audits (ISO), FDA audits and other regulatory compliant activities.
- Assist with sterilization processing activities including sterilization record review, Gamma quarterly audits, and/or EO annual re-validation.
- Supervise employees as assigned.
· 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+ yrs medical device experience and an AA/ AS degree in science, technology or equivalent. Mastered the use of quality control disciplines, tools, and analyzing methodologies. 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, Change Control (ECO), Non-Conforming, CAPA, Sterilization, Packaging, Shelf Life Validation, and general Quality Systems compliance. Preferred experience working with complex energy-based medical electrical systems and products such as high frequency RF, Laser, Ultrasound, Microwave or Cryosurgery, etc.