Biomedical Quality Engineer

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
• Assess the complaint to be reportable by applying knowledge of medical device regulatory requirements.
• Provide root cause investigation on the returned product.

Qualifications 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

• Experience in Quality Systems (ISO 13485), Risk Management (ISO 14971), Auditing, Complaint Handling, Corrective, and Preventative Actions (CAPA)

• Excel user comfortable creating pivot tables

Job Type: Contract

Salary: $40.00 - $48.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Experience:

• Medical device: 10 years (Required)
• Quality Investigation: 10 years (Required)

Ability to Commute:

• Alpharetta, GA 30004 (Preferred)

Work Location: In person