Job Description
Job Summary:
The Quality Assurance Specialist I supports the global quality organization by managing product complaints for pharmaceutical, medical device, and combination products. This role focuses on complaint documentation, investigation, and regulatory compliance while collaborating with cross-functional teams and external stakeholders. The position requires strong analytical skills, attention to detail, and the ability to manage multiple priorities in a regulated environment.
Key Responsibilities:
• Review and process product complaints to ensure compliance with global quality and regulatory requirements
• Conduct complaint documentation, investigation, and evaluation of non-medical and quality-related issues
• Identify potentially reportable events and notify appropriate functional teams and management
• Ensure all complaint records meet Good Documentation Practices and applicable regulatory standards
• Coordinate product return samples, investigation activities, and customer follow-up actions
• Prepare customer communications and support regulatory report submissions as required
• Interface with healthcare professionals, internal stakeholders, third-party partners, and regulatory bodies
• Maintain accurate and complete complaint files to support audit readiness and compliance
Required Qualifications:
• Bachelor’s degree in a scientific, healthcare, or related field
• Experience or educational background in pharmaceutical, medical device, or product complaint handling
• Strong critical thinking, analytical, and problem-solving skills
• Excellent written and verbal communication skills
• Proficiency in Word, Excel, PowerPoint, Outlook, and Teams
• Ability to prioritize tasks and manage multiple responsibilities effectively
Preferred Qualifications:
• Knowledge of global regulatory requirements for pharmaceutical and medical device products
• Familiarity with quality system regulations and complaint handling processes
• Understanding of regulatory reporting requirements and industry standards
• Experience working in a regulated environment or clinical setting
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $20/hr to $25/hr