Quality Assurance Engineer
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.
The Quality Assurance Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX system, disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts. In addition, this position will support the development and implementation of quality systems and compliance activities.
Essential Duties and Responsibilities
- Lead the implementation of quality processes using current PLM system from Arena.
- 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.
- Support internal audits and other regulatory compliant activities.
- Participate and lead supplier audit of critical suppliers.
- Perform statistical analysis of key quality processes and participate in MRB as needed.
- Development of quality procedure in support of quality inspection and testing, and provide training to QC personnel.
- 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.
- Support management review activities, Notified Body audits (ISO), FDA audits.
- Lead UDI and GUDID compliance program to ensure every device is appropriately identified and registered.
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
Education and Experience
- BS degree in science, engineering, or technology field or equivalent experience.
- Minimum 1-2 years of medical device experience.
Skills, Abilities, and Other Requirements
- Knowledge and understanding of FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485 requirements.
- Knowledge and understanding in the following areas:
- Quality system compliance
- Change control
- Design control
- Complaint handling
- CAPA management
- DHF/DHR review and audit
- Knowledge of quality disciplines, tools, and methodologies.
- Proficient knowledge and skill in Microsoft Office Suite applications.
- Excellent oral written communication skills, critical thinking skills and project management 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, fast growing company.
- Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
- Ability to lift 10-15 pounds.
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.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.