About the Role
The Sr. QA Compliance Specialist will be responsible for ensuring all company and customer quality standards are met. This individual participates in the implementation of various quality processes in support of compliance with cGMP/QSR (21 CFR 820). She/he is responsible for performing quality assurance related functions independently including but not limited to maintaining the quality system in accordance with ISO 13485.
To Make an Impact, You Will:
• Cultivate the organization's Quality Policy and Quality System. • Manage Pulse Biosciences' Complaint, Non-conforming (NCMR) and Corrective Action (CAPA) compliance activities. • Lead the complaint handling process using current PLM system, Arena; working collectively with Customer Service, Engineering and other departments. • Coordinate and support the investigation and closure of complaints, NCMRs and CAPAs and facilitate documentation and records. • Perform statistical analysis of Complaint, NCMR and CAPA processes. • Lead Complaint, NCMR and CAPA meetings. • Support and maintenance of the supplier management process; working collectively with Supply Chain and Legal through the evaluation and approval of suppliers. • Establish post-market surveillance and periodic safety update reports as required. • Support vigilance and medical device reporting activities, including Advisory Notices, Field Safety Notices (FSN), Field Safety Corrective Action (FSCA) working with Regulatory Affairs. • Support final QA Test, review of DHRs, and perform product release processing in accordance with documented procedures. • Support incoming inspections, as needed. • 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. • Assist with sterilization processing activities including sterilization record review. • Support internal audits, Notified Body audits (ISO), FDA inspections and other regulatory compliant activities, where necessary. • Ensure that all documentation is in compliance with Pulse Biosciences Quality System policies and procedures and maintain current knowledge of the GMP/QSR and ISO/MDR regulations. • Support and maintain electronic and hard copy library of clinical and technical publications as needed. • Ensure compliance with regulatory bodies, organization's policies and applicable laws.
May perform other duties as assigned.
To Excel, You Will Bring:
• BA/BS degree in science or equivalent experience. • 5+ years' experience, preferably in medical devices, in a quality function or related experience in the life science industry. • 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. • Ability 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 judgement, 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.
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $100k - $125k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area.