QA Specialist – Complaint Handling

ZEISS•Ontario, CA

1d•Onsite

About The Position

How many companies can say they’ve been in business for over 179 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team! 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.

Requirements

High school diploma or equivalent with 3+ years of relevant experience required.
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 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.
Ability to read, interpret, and communicate technical documents, procedures, and correspondence.
Comfortable presenting information in one-on-one and small group settings.

Nice To Haves

Bachelor’s degree in Engineering, Clinical Sciences, Life Sciences, or a related field preferred.
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 Quality Management Systems (QMS) and quality management software is preferred.
Bilingual capabilities are a plus.

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.