Quality Assurance Associate

Quality Assurance Associate

The Quality Assurance Associate supports a robust quality system by managing product complaints, conducting investigations, and ensuring compliance with applicable regulations and internal procedures. This role independently handles customer inquiries, performs detailed complaint evaluations, supports regulatory reporting, and contributes to process improvements that enhance product quality and customer satisfaction.

• Independently field inquiries received by phone, electronic, or verbal correspondence and determine whether they qualify as complaints in accordance with applicable standard operating procedures.
• Document reported issues accurately and completely, following all relevant SOPs and quality system requirements.
• Provide technical support and remote troubleshooting guidance to users and customers as needed.
• Review associated records independently and contact users and customers to collect detailed information on treatments, product performance, and functionality.
• Conduct periodic follow-up with customers and internal stakeholders to ensure timely closure of complaints.
• Manage customer relationships and expectations throughout the complaint investigation process, maintaining clear and professional communication.
• Independently complete complaint investigations, including coordinating or executing product returns and subsequent evaluations as required.
• Review manufacturing records and other relevant documentation as part of complaint investigations, ensuring proper approvals are obtained prior to closure.
• Develop practical solutions to a variety of moderately complex problems related to product quality and performance.
• Conduct statistical analysis of complaint trends and provide insights that support quality improvement initiatives.
• Support the training program by training users on the complaint process, tools, and methods used to assess and investigate complaints.
• Support and, when appropriate, identify operational changes to improve efficiencies in all aspects of complaint handling.
• Sometimes lead investigations associated with product deviations, product non-conformances, corrective and preventive actions (CAPAs), scrap, and rework, and analyze data to identify root causes and opportunities for quality improvement.
• Update internal operating procedures and specifications through the document change process to reflect process improvements and regulatory requirements.
• Support and participate in internal quality system audits by providing documentation, explanations, and follow-up actions.
• Support external quality system audits by assisting with preparation, participating in audit activities, and implementing corrective actions as needed.
• Evaluate complaints to determine whether submission of a Medical Device Report (MDR) or other Vigilance Report is required based on regulatory criteria.
• Prepare and submit MDRs and Vigilance Reports within required regulatory timelines, ensuring accuracy and completeness of information.

• Experience in quality assurance or other regulated industry or similar experience (preferred).
• Knowledge of quality principles and practices, including inspection activities.
• Familiarity with FDA regulations and expectations for regulated products.
• Understanding of Good Manufacturing Practices (GMP).
• Understanding of Good Laboratory Practices (GLP).
• Experience or exposure to medical device (Med
  * Device) quality or regulatory environments.
• Strong technical writing skills, with the ability to document investigations, complaints, and reports clearly and accurately (required).
• Strong general problem-solving skills and the ability to develop solutions to moderately complex issues (required).
• Ability to manage multiple priorities and work effectively despite interruptions (required).
• Customer service skills, including the ability to manage customer expectations and maintain professional communication.
• Proficiency with Microsoft Excel for tracking, trending, and statistical analysis of complaint data.

• Bachelor of Science (BS) in a Physical Science or Engineering, or equivalent experience (required).
• Experience working within a quality system in a regulated industry, such as medical devices, pharmaceuticals, or related fields (preferred).
• Experience supporting or participating in internal and external quality system audits.
• Experience with complaint handling processes, including documentation, investigation, and closure.
• Familiarity with Medical Device Reporting (MDR) and Vigilance reporting requirements and timelines.
• Ability to adapt to constant and sometimes sudden changes in role, processes, or organizational priorities.
• Strong interpersonal and communication skills for collaborating with cross-functional teams and training users on complaint processes.
• Attention to detail and accuracy in documentation, data analysis, and regulatory reporting.

This is a first-shift position with core hours of 7:00 a.m. to 3:30 p.m.,…