Quality Assurance Specialist

Responsibilities

• Enter and manage customer complaints in the IQMS CAR system with precision, ensuring all details are captured to facilitate swift resolution and compliance.
• Lead thorough investigations into customer complaints, conducting in-depth analysis of root causes and trends. Ensure timely and transparent communication to management on complaint trends through detailed weekly, monthly, and quarterly reports.
• Actively follow up with customers via phone and email to gather essential information for accurate complaint investigation, ensuring a positive and professional experience.
• Analyze device history records, manufacturing documents, and other relevant sources to support complaint investigations. Conduct preliminary cause analysis and promptly alert management of any nonconformance or risks.
• Collaborate with cross-functional teams and subject matter experts (SMEs) to lead root cause analysis, driving corrective and preventive actions (CAPA) to resolve underlying issues.
• Perform basic dimensional and cosmetic inspections using precision tools like calipers and micrometers, ensuring product quality aligns with technical drawings, specifications, and industry standards.
• Provide critical support to other departments throughout the complaint resolution process, fostering a collaborative and results-oriented environment.
• Develop, monitor, and maintain key performance indicators (KPIs) and dashboards that provide insight into complaint trends, driving continuous improvement within the department.
• Oversee final lot history reviews and ensure the issuance of Certificates of Conformance (CoC) to maintain customer satisfaction and product quality assurance.
• Adhere to all safety guidelines and protocols while performing duties and take on additional tasks as directed by Quality Engineers or Managers to support the team’s overall goals.

Qualifications

• Associate’s degree or equivalent experience/training required. A bachelor's degree is preferred.
• 3-5 years of experience in a manufacturing environment, ideally within a regulated industry.
• Familiarity with 21 CFR Parts 820 and ISO 13485 or 9001 quality systems is preferred.
• Experienced with creating and implementing a quality management system (QMS).
• Strong background in visual and dimensional inspection, particularly in molded products and plastic injection molding processes.
• Ability to communicate complex technical information clearly, both verbally and in writing, with internal teams and customers.
• Proven experience working in a manufacturing environment, with a strong understanding of safety standards and procedures.