Sr. QA Compliance Specialist

Pulse Biosciences (Nasdaq: PLSE) is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.  The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

At Pulse, we: 

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

About the Role

As the Sr. QA Compliance Specialist, you will ensure company and customer quality standards are met. You will participate in the implementation of various quality processes in support of compliance with cGMP/QSR (21 CFR 820). You will be responsible for performing quality assurance related functions independently including but not limited to maintaining the quality system in accordance with ISO 13485.

You will make an impact by:

• Cultivating the organization’s Quality Policy and Quality System.
• Managing Pulse Biosciences’ Complaint, Non-conforming (NCMR) and Corrective Action (CAPA) compliance activities. 
• Leading the complaint handling process using current PLM system, Arena; working collectively with Customer Service, Engineering and other departments.
• Coordinating and supporting the investigation and closure of complaints, NCMRs and CAPAs and facilitate documentation and records.
• Performing statistical analysis of Complaint, NCMR and CAPA processes.
• Leading Complaint, NCMR and CAPA meetings.
• Supporting and maintaining the supplier management process; working collectively with Supply Chain and Legal through the evaluation and approval of suppliers.
• Establishing post-market surveillance and periodically safety update reports as required.
• Supporting vigilance and medical device reporting activities, including Advisory Notices, Field Safety Notices (FSN), Field Safety Corrective Action (FSCA) working with Regulatory Affairs.
• Supporting final QA Test, review of DHRs, and performing product release processing in accordance with documented procedures.
• Supporting incoming inspections, as needed.
• Performing data collection and statistical analysis of product yields from inspection and final QA. 
• Ensuring products are compliant with quality, regulatory standard requirements for clinical and/or commercial distribution. 
• Assisting with sterilization processing activities including sterilization record review.
• Supporting internal audits, Notified Body audits (ISO), FDA inspections and other regulatory compliant activities, where necessary.
• Ensuring that all documentation is in compliance with Pulse Biosciences Quality System policies and procedures and maintaining current knowledge of the GMP/QSR and ISO/MDR regulations.
• Supporting and maintaining electronic and hard copy library of clinical and technical publications as needed.           
• Ensuring compliance with regulatory bodies, organization’s policies and applicable laws.
• May perform other duties as assigned. 

To be successful, you will bring: 

• Experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements required. 
• Proficient knowledge and skills in Microsoft Office applications. 
• Arena experience preferred.
• Excellent oral written communication and critical thinking skills.
• Be able to collaborate, communicate and work effectively with multiple team members on product quality issues, procedural compliance, and other business activities.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions.
• 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.
• Willing and able to travel up to 20% of the time.
• Strong communication and active listening skills.
• Ability to lift 10-15 pounds.  

 You’ll experience:  

• Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment! 
• A variety of health insurance plans and supplemental insurance options.        
• 401k retirement savings plan.
• Stock options awards and ESPP program.
• Paid time off, paid holidays, and flexible work schedule.
• Wellness program with free onsite gym, mindfulness classes and activities.
• A commitment 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.
 

To learn more about us, visit our website at www.pulsebiosciences.com. 

LOCAL CANDIDATES ONLY

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