QA Specialist - Complaint Handling

Overview To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QA Specialist is responsible for managing complaint handling, returned goods tracking and reporting requirements. The QA Specialist will be responsible for working with the Engineering, Manufacturing and Quality Assurance teams coordinating activities required for investigations including failure analysis, nonconformance and CAPA related to complaints. The position requires reporting returns to regulatory agencies as required and close investigations within appropriate timeframes. Responsibilities Manage the end-to-end product complaint process, ensuring timely and compliant handling from intake through closure. Evaluate, investigate, and resolve customer complaints in accordance with internal procedures and applicable regulations, including ISO 13485, FDA 21 CFR 820, and MDSAP requirements. Conduct and coordinate root cause investigations by gathering data, performing product evaluations, and collaborating with cross‑functional teams. Maintain complete, accurate, and compliant complaint records, documenting investigation results, conclusions, and supporting rationale. Partner with Manufacturing, R&D, Regulatory Affairs, Quality, and Supply Chain teams to drive effective complaint resolution. Communicate with customers, distributors, and internal stakeholders to obtain information and provide updates throughout the investigation process. Support escalation activities for potential safety concerns or systemic quality issues. Coordinate returned product evaluations, ensuring traceability and proper documentation. Maintain complaint files and data within the complaint management system in accordance with Good Documentation Practices (GDP). Analyze complaint trends and perform statistical evaluations to identify recurring issues, emerging risks, and areas for improvement. Prepare and present complaint trend reports to Quality and Management Review teams and provide input for CAPA activities and risk assessments. Assess complaints for regulatory reportability requirements, including Medical Device Reporting (MDR) and global vigilance obligations, and support submissions to regulatory authorities as required. Initiate and support Corrective and Preventive Actions (CAPA), verify effectiveness of implemented actions, and drive continuous improvement initiatives. Participate in internal audits and support external audits, including ISO, MDSAP, and regulatory inspections. Contribute to maintaining an effective and compliant Quality Management System (QMS). Support departmental goals and key performance indicators, including complaint closure timelines, trend analysis effectiveness, CAPA linkage, and overall quality performance. Lead and complete assigned projects in alignment with business objectives and established timelines. Qualifications High school diploma or equivalent with 3+ years of relevant experience required. Bachelor's degree in Engineering, Clinical Sciences, Life Sciences, or a related field preferred. Minimum of 3 years of post‑market complaint handling experience within a regulated industry, with a strong understanding of global medical device regulations and quality standards, including ISO 13485 and FDA Quality System Regulations (QSR). Experience in the medical device industry preferred; experience in other regulated industries such as Pharmaceuticals or In Vitro Diagnostics (IVD) is also valued. Experience with technical writing and the development of procedures, work instructions, or policies. Proficiency with Microsoft Office and other computer applications; advanced computer skills are preferred. Experience with Quality Management Systems (QMS) and quality management software is preferred. Ability to read, interpret, and communicate technical documents, procedures, and correspondence. Comfortable presenting information in one‑on‑one and small group settings. Bilingual capabilities are a plus. Work Schedule This is a full‑time, on‑site position located at our facility. Remote work is not available for this role. Standard working hours are Monday through Friday, 7:00 AM to 3:30 PM, with occasional overtime as business needs require. Compensation The hourly pay range for this position is $31.00 - $38.00. Actual compensation will depend on factors such as location, experience, education, skills, and role scope. Eligible for performance bonus or sales commissions. Benefits Medical Vision Dental 401(k) Matching Employee Assistance Programs Vacation and sick pay The list goes on! The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion. Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends). #J-18808-Ljbffr