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TPI Global (formerly Tech Providers, Inc.)
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Compliant Investigation Specialist IV
Posted: 01/25/2024
2024-01-25
2024-03-22
Job Number: 21166069
Job Description
Position: Compliant Investigation Specialist IV
Location: Alpharetta GA, 30004 (Onsite)
Duration: 12+ months contract
Shift time: 08 AM to 05 PM EST.
Must have excellent Presentation creation skills
Job Summary:
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.
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”.
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.
Location: Alpharetta GA, 30004 (Onsite)
Duration: 12+ months contract
Shift time: 08 AM to 05 PM EST.
Must have excellent Presentation creation skills
Job Summary:
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.
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”.
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.
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Discover exciting job opportunities in the vibrant area around Alpharetta, Georgia! Known for its thriving tech industry, abundant green spaces like the Big Creek Greenway, and fantastic dining scene featuring Southern specialties like shrimp and grits, Alpharetta offers a perfect blend of career growth and quality of life. With attractions like the Ameris Bank Amphitheatre for live music performances and the Avalon shopping area for upscale shopping and dining, Alpharetta provides a charming backdrop for your professional journey. Start your career exploration today by checking out our current job listings in this dynamic region!