Senior QA Compliance Specialist

Senior QA Compliance Specialist

W2 Contract

Pay Rate: $50 - $60 per hour

Location: Hayward, CA - Onsite 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). They are responsible for performing quality assurance-related functions independently, including but not limited to maintaining the quality system in accordance with ISO 13485.

• Cultivate the organization's Quality Policy and Quality System.
• Manage 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), 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 our 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.

• 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.
• 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 judgement, taking initiative to accomplish short and long‑range projects, and recommend 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.

• Quality Assurance (QA)
• QA Compliance
• Quality Systems Management
• Quality Policy Development
• cGMP
• QSR (21 CFR Part 820)
• 21 CFR Part 11
• ISO 13485
• ISO/MDR Regulations
• FDA Regulations
• Medical Device Quality
• Complaint Handling
• Nonconforming Material Reports (NCMR)
• Corrective and Preventive Actions (CAPA)
• PLM Systems (Arena)
• Cross-Functional Collaboration
• Statistical Analysis
• Post-Market Surveillance
• Periodic Safety Update Reports
• Vigilance Reporting
• Medical Device Reporting (MDR)
• Advisory Notices
• Field Safety Notices (FSN)
• Field Safety Corrective Actions (FSCA)
• Regulatory Affairs Support
• Supplier Quality Management
• Supplier Evaluation and Approval
• Final QA Testing
• Device History Record (DHR) Review
• Product Release
• Incoming Inspection
• Product Yield Analysis
• Sterilization Record Review
• Internal Audits
• Notified Body Audits
• FDA Inspections
• Regulatory Compliance
• Documentation Control
• Quality System Maintenance
• Clinical and Commercial Product Compliance
• Microsoft Office
• Data Collection and Analysis
• Technical Documentation Management
• Critical Thinking
• Written and Verbal Communication
• Cross-Functional Team Leadership
• Independent Work
• Process Improvement
• Life Sciences Industry Experience
• Travel Flexibility

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your…