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Quality Analyst/Complaints Manager

Ad-Tech Medical Instrument Corp Oak Creek, WI

  • Posted: over a month ago
  • $25 to $30 Hourly
  • Full-Time
  • Benefits: 401k, dental, life insurance, medical, vision
Job Description

Education and/ or Experience Required:

1.       Preferred: Bachelor’s Degree in Clinical, Science, Engineering or other technical field; or 2 - 3 years related experience and/or training; or equivalent combination of education and experience.


The following qualifications are preferred:

·         Active Learning

·         Active Listening

·         Critical Thinking

·         Learning Strategies

·         Self-Assessment

·         Excellent communication and listening skills

·         College level Reading, Writing and Speaking (English)

·         Problem Solving

·         Attention to Details

·         Proficiency in MS Programs

·         Professionalism

·         Handles Pressure

·         Consistent application of Quality System standards to assigned Quality System area; working knowledge of Quality Systems Regulatory requirements

·         Understanding of complaint handling, experience with QCBD preferred

·         Strong knowledge of Microsoft Office (Excel, Work and PowerPoint)


Essential Duties and Responsibilities - Duties may include but are not limited to:

·         Consistent application of Quality System standards to assigned Quality System area

·         Develops solutions to routine assigned activities of moderate scope & complexity

·         Follows applicable Company/Unit procedures may make updates to procedures and policies

·         Works within and across functions for assigned Quality Systems

·         Working knowledge of Quality Systems Regulatory requirements and the application to company/unit requirements

·         Accountable for setting own work direction and completing tasks

·         Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses to customers

·         Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible

·         Recommend corrective and/or preventative action(s) related to customer complaint issues

·         Identify and monitor patterns and trends in complaint issues related to assigned product groups

·         Provide documented reports outlining the investigation process, investigation findings, frequency of related events, corrective actions and recommendations.

·         Escalate high priority issues as well as identify business risks to appropriate management level

·         Escalation of complaints and assist in complaint investigations as required

·         Review all customer complaints, investigations and communications for validity and assure compliance with policies and procedures

·         Development of complaint closure letters as required

·         Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports

·         Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements

·         Responsible for reviewing customer complaints received for Medical Device Records, FDA and ISO requirements

·         Provide internal guidance and education regarding customer complaint processing, MDRs and regulatory compliance

·         File MedWatch reports after leader review and approves, if applicable

·         Perform other duties as assigned


Additional Responsibilities:

·         Contributes to the completion of specific programs and projects

·         Develop, implement and follow procedures to ensure timely and accurate receipt of documentation, analysis, and response to customer complaints

·         Ensure customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting

·         Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary


Supervisory Responsibilities: None

Ad-Tech Medical Instrument Corp


400 West Oakview Parkway

Oak Creek, WI



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