Compliant Investigation Specialist - Quality Analyst

Title: Compliant Investigation Specialist - Quality Analyst

Location: Alpharetta GA 30004

Duration: 6+ Months (Possible Extension/Conversion)

Shift Hours: Mon – Fri (8am to 5pm)

Description/Comment

The major purpose of this position is to support the on-going activities required to support the assigned product family activities. These activities include but are not limited to:

• Investigation of customer complaints
• Review of customer complaint trends
• Support and participate in complaint process improvement initiatives.
  
  

Job Position Scope (Optional)

The scope of the Quality Assurance Specialist position is to:

• Efficiently performing Complaint Handling (Investigations and/or Approvals) and Failure Investigation (Quality Assurance)
• Communicate complaint status, and challenges effectively to project team(s)
  
  

Job Position Accountabilities / Expectations

• Develop and document customer complaint investigations.
• Identification and risk management of customer complaints.
• Evaluate, document, and communicate customer complaint trends.
• Analyze reports of defects and process issues to determine trends.
• Analyze trends and identify potential root causes
• Conduct statistical analyses and document resulting risk analyses
• Ensure that the applicable procedures are put into practice correctly. If lack of clarity is identified in procedures, report and promote the pertinent changes for clarification.
• Recommendation for improvement of procedures as applicable.
• Coordinate and/or train on new or modified procedures.
• Participate in cross-functional continuous improvement projects or teams.
  
  

Key Relationships / Customer Expectations

The Key Relationships / Customer Expectations of Complaint Investigation Specialist position is to understand all levels of management within Technical Quality, Quality Systems, Global Post-Market Surveillance, Research & Development, and Project Management

Key Leadership Values (Optional)

The Key Leadership Values of the Complaint Investigation Specialist position is to:

• Conduct self in accordance with the expected approved corporate values.
• Motivated to promote and achieve goals in-line with project leadership and targets.
  
  

Qualifications / Education / Experience (Required)

• B.S. in Quality Assurance or Quality Systems with a minimum of 10 years of collective experience in a medical device required:
• Experience in Complaint Investigation and assessing patient risk
• Experience writing conclusions of root cause analysis, summaries of complaint investigations, and communicating results
• Proficient with Microsoft Office programs
• Presentation Creation
  
  

Specialized Or Essential Knowledge (Preferred)

• Experience in Quality Systems (ISO 13485), Risk Management (ISO 14971), Auditing, Complaint Handling, Corrective, and Preventative Actions (CAPA).
• Excel user comfortable creating pivot tables.
  
  

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