Cynet systems Inc
Complaints Management Specialist
Cynet systems Inc, Vernon Hills, Illinois, United States, 60061
Job Description
Pay Range: $39.82hr - $43.82hr
The Quality Systems Specialist will be responsible for ensuring consistent application of Quality System standards, managing customer complaints, and maintaining compliance with FDA and ISO requirements.
This role requires strong analytical and documentation skills, as well as experience in complaint handling and quality system processes.
Responsibilities
Apply Quality System standards consistently within assigned areas.
Develop solutions for routine and moderately complex quality-related activities.
Follow applicable company and unit procedures, and contribute to procedure and policy updates.
Work collaboratively across departments to ensure compliance with quality system requirements.
Manage the end-to-end process of customer complaints, including review, documentation, and response.
Investigate customer complaints, identifying root causes and contributing factors.
Recommend and track corrective and preventive actions (CAPA) based on complaint findings.
Identify and monitor patterns or trends in complaint issues related to assigned products.
Prepare clear and detailed investigation reports outlining findings, frequency, corrective actions, and recommendations.
Develop test protocols and reports when necessary.
Escalate high-priority issues and potential business risks to appropriate management levels.
Review all customer complaints, investigations, and communications for validity and compliance.
Draft and issue Complaint Closure Letters as required.
Collaborate with Regional Complaint Centers to address complaint-handling issues.
Utilize complaint database systems to manage cases, generate quality metrics, and process electronic MDR reports.
Contribute to MDR guideline development for identifying failures that require malfunction reporting.
Review complaints for Medical Device Reporting (MDR) compliance with FDA and ISO standards.
Provide internal training and guidance on complaint processing, MDRs, and regulatory requirements.
Prepare and file MedWatch reports upon approval.
Support cross-functional quality initiatives and continuous improvement projects.
Ensure all complaint handling activities align with FDA and ISO requirements.
Exhibit flexibility by managing multiple priorities and adapting to project needs.
Represent the business unit on cross-functional quality system teams.
Experience
Minimum 2–3 years of relevant experience in quality systems or complaint handling, or an equivalent combination of education and experience.
Experience with complaint handling systems (TrackWise preferred).
Strong understanding of FDA and ISO quality system requirements.
Skills
Proficiency in Microsoft Excel, Word, and PowerPoint.
Strong analytical, documentation, and problem-solving abilities.
Excellent verbal and written communication skills.
Ability to manage multiple priorities and meet deadlines in a regulated environment.
Qualification and Education
Bachelor’s degree required (preferably in Clinical, Science, or Engineering disciplines).
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The Quality Systems Specialist will be responsible for ensuring consistent application of Quality System standards, managing customer complaints, and maintaining compliance with FDA and ISO requirements.
This role requires strong analytical and documentation skills, as well as experience in complaint handling and quality system processes.
Responsibilities
Apply Quality System standards consistently within assigned areas.
Develop solutions for routine and moderately complex quality-related activities.
Follow applicable company and unit procedures, and contribute to procedure and policy updates.
Work collaboratively across departments to ensure compliance with quality system requirements.
Manage the end-to-end process of customer complaints, including review, documentation, and response.
Investigate customer complaints, identifying root causes and contributing factors.
Recommend and track corrective and preventive actions (CAPA) based on complaint findings.
Identify and monitor patterns or trends in complaint issues related to assigned products.
Prepare clear and detailed investigation reports outlining findings, frequency, corrective actions, and recommendations.
Develop test protocols and reports when necessary.
Escalate high-priority issues and potential business risks to appropriate management levels.
Review all customer complaints, investigations, and communications for validity and compliance.
Draft and issue Complaint Closure Letters as required.
Collaborate with Regional Complaint Centers to address complaint-handling issues.
Utilize complaint database systems to manage cases, generate quality metrics, and process electronic MDR reports.
Contribute to MDR guideline development for identifying failures that require malfunction reporting.
Review complaints for Medical Device Reporting (MDR) compliance with FDA and ISO standards.
Provide internal training and guidance on complaint processing, MDRs, and regulatory requirements.
Prepare and file MedWatch reports upon approval.
Support cross-functional quality initiatives and continuous improvement projects.
Ensure all complaint handling activities align with FDA and ISO requirements.
Exhibit flexibility by managing multiple priorities and adapting to project needs.
Represent the business unit on cross-functional quality system teams.
Experience
Minimum 2–3 years of relevant experience in quality systems or complaint handling, or an equivalent combination of education and experience.
Experience with complaint handling systems (TrackWise preferred).
Strong understanding of FDA and ISO quality system requirements.
Skills
Proficiency in Microsoft Excel, Word, and PowerPoint.
Strong analytical, documentation, and problem-solving abilities.
Excellent verbal and written communication skills.
Ability to manage multiple priorities and meet deadlines in a regulated environment.
Qualification and Education
Bachelor’s degree required (preferably in Clinical, Science, or Engineering disciplines).
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