Quality Assurance Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the implementation, maintenance, and ongoing enhancement of Quality Management System (QMS) processes.

• Collaborate with cross-functional teams to carry out CAPA activities, which include providing investigation support, tracking actions, verifying effectiveness, and preparing for closure.

• Aid and conduct quality investigations, encompassing root cause analysis, data collection, risk evaluation, corrective action formulation, and Verification of Effectiveness (VOE).

• Oversee CAPA activities by monitoring timelines, following up on assigned tasks, identifying potential completion risks, and driving documentation towards closure.

• Enhance and maintain quality system procedures, work instructions, templates, forms, and records.

• Support change control processes, including document revisions, tracking implementations, and facilitating cross-functional coordination.

• Conduct data analysis, trend assessments, and reporting of quality metrics.

• Assist with internal and external audits and regulatory inspections, including preparing documentation and ensuring follow-up actions are completed.

• Aid in maintaining inspection readiness and ensure that quality records are thorough, accurate, and ready for audit.

• Engage in continuous improvement initiatives aimed at fortifying quality systems, streamlining processes, and enhancing compliance and operational efficiency.

• Execute additional responsibilities as assigned by Management.

⛳️ Requirements

• Bachelor’s degree in Life Science, Engineering, Quality, or a related technical field.

• 2–5 years of experience in Quality Assurance, Quality Systems, or Quality Engineering within a regulated environment.

• Familiarity with FDA 21 CFR Part 820/QMSR, ISO 13485, and relevant quality system requirements.

• Experience with Quality Management System (QMS) processes, including CAPA, investigations, change control, document management, training, and nonconformance oversight.

• Proficient in eQMS/document control systems (e.g., Arena PLM) and Microsoft Office applications.

• Excellent analytical, problem-solving, organizational, and communication abilities with a keen attention to detail.

• Preferred experience with quality metrics, data trends, and reporting.

• Capability to manage multiple priorities, work autonomously, and drive tasks to completion in a dynamic environment.

• Strong written and verbal communication skills with the ability to collaborate across departments and mentor others on quality system expectations.

• Detail-oriented with a commitment to precision, compliance, and high-quality documentation.

🏝️ Benefits

• Competitive salary.

• Comprehensive health insurance, including Medical, Dental, and Vision, along with HSA and FSA options.

• 401K and stock purchase plans.

• Equity & Bonus Program.

• Company-paid Life Insurance & supplemental options, as well as Disability insurance.

• Mental health support through medical insurance programs.

• Legal and Pet Insurance.

• 12+ paid holidays, Flexible Time Off, and Sick Time.

• Paid parental leave.

• In-office snacks and beverages.

• In-office lunch stipend.

• Learning & Development Opportunities: On-demand online training and book reimbursement.

• Team building and company-organized social events and celebrations.

• Tuition reimbursement.

• Flexible work arrangements available, including remote, hybrid, field, or office schedules.