Senior Quality Assurance Technician

Location
Hayward, CA
Posted
Oct 05, 2021
Ref
1091
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time


Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.   Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.   

 

 

Position Summary:

The Senior Quality Assurance Technician will ensure company and customer quality standards are met. This individual will participate in the implementation of various quality processes in support of compliance with cGMP/QSR (21 CFR 820). The incumbent will perform quality assurance related functions independently including but not limited to documentation review of product releases and maintaining the documentation in accordance with ISO 13485 quality systems.

 Essential Duties and Responsibilities: 
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the organization’s Quality Policy and Quality System.
  • Conduct quarterly bioburden testing of sterile products in accordance with documented process.
  • Work directly with investigation teams on critical quality issues, including returned products.
  • Evaluate and implement protocols and methods for inspection and testing of in-process raw materials and finished products.  
  • Prepare documentation for inspection/testing such as quality inspection procedures.  
  • Support final QA Test, review of DHRs, and perform product release processing in accordance with documented procedures.
  • Support incoming inspections and participate in MRB, as needed.
  • Assist with equipment calibration/preventive maintenance tracking system and processes.
  • Perform data collection and statistical analysis of product yields from inspection and final QA. 
  • Ensure products are compliant with quality, regulatory standard requirements for clinical and/or commercial distribution. 
  • Be able to collaborate, communicate and work effectively with multiple team members on product quality issues, procedural compliance, and other business activities.
  • Assist with sterilization processing activities including sterilization record review.
  • Support internal audits, Notified Body audits (ISO), FDA audits and other regulatory compliant activities, where necessary.
  • May perform other duties as assigned.
 

Education and Experience:

  • 8+ years of medical device experience and an Associates degree in science, or equivalent. 
  • 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 Product, CAPA, Sterilization, Packaging, and general Quality Systems compliance.
  • Experience with quality lab tools, such as micrometers, calipers and vision systems. 

 

 

Skills, Abilities, and Other Requirements:

  • Proficient knowledge and skill in Microsoft Office applications.
  • Excellent oral written communication skills and critical thinking skills.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic and growing company.
  • Strong visual inspection skills.
  • Strong communication and active listening skills.
  • Ability to lift 10-15 pounds.  

 

Pulse Biosciences currently maintains a policy requiring all United States-based employees to be fully vaccinated against COVID-19. In accordance with applicable law, Pulse Biosciences will consider reasonable accommodations to employees who qualify as required under federal, state and local law where it is not an undue hardship to the company to do so. 

 

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com

 

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities. 

 

 

LOCAL CANDIDATES ONLY

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.