Quality Assurance Compliance Specialist

Quality Assurance Compliance Specialist

Direct Hire Full-Time Role

Pay Rate: $48 - $58 per hour

Location: Hayward, CA - Onsite Role

Job Summary:

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.

Duties and Responsibilities:

• 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 the 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), and 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 and 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 an electronic and hard copy library of clinical and technical publications as needed.
• Ensure compliance with regulatory bodies, the organization's policies, and applicable laws.
• May perform other duties as assigned.

Requirements and Qualifications:

• BA/BS degree in science or equivalent experience.
• 5 years' experience 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 and 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 recommending actions.
• Ability to work as a team member, multitask, 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.

Desired Skills and Experience

Quality Assurance, QA Compliance, Medical Devices, Life Sciences, cGMP, QSR, 21 CFR 820, 21 CFR Part 11, ISO 13485, Quality Management System, Quality System, Quality Policy, Complaint Handling, Complaints, Nonconformance, NCMR, CAPA, Corrective and Preventive Action, PLM, Arena, Customer Service Collaboration, Engineering Collaboration, Complaint Investigation, CAPA Investigation, Documentation, Records Management, Statistical Analysis, Supplier Management, Supplier Evaluation, Supplier Approval, Supply Chain Collaboration, Legal Collaboration, Post-Market Surveillance, Periodic Safety Update Reports, Vigilance Reporting, Medical Device Reporting, MDR, Advisory Notices, Field Safety Notices, FSN, Field Safety Corrective Action, FSCA, Regulatory Affairs, Final QA Testing, DHR Review, Device History Records, Product Release, Incoming Inspection, Product Yield Analysis, Regulatory Compliance, Clinical Distribution, Commercial Distribution, Sterilization Processing, Sterilization Record Review, Internal Audits, Notified Body Audits, FDA Inspections, ISO Audits, GMP, ISO Regulations, MDR Regulations, Document Control, Technical Publications, Clinical Publications, Microsoft Office, Written Communication, Oral Communication, Critical Thinking, Cross-Functional Collaboration, Procedural Compliance, Product Quality, Teamwork, Multitasking, Independent Judgment, Initiative, Project Execution, Active Listening

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