Key skills
R
About this role
United Pharma is seeking Product Quality Engineers with medical device post market experience to support field quality investigations and risk assessments for on market products. The role involves leading complaint investigations, performing health risk assessments, and collaborating with various teams to implement corrective actions.
Responsibilities:
- Lead complaint investigations and root cause analysis for field issues
- Perform Health Risk Assessments (HRA) for product quality concerns
- Support post market quality engineering activities
- Collaborate with R&D, Operations, and field teams to implement corrective actions
- Monitor and present product quality and complaint trends
- Support internal audits and regulatory inspections including FDA
Requirements:
- Experience in post market quality engineering within the medical device industry
- Strong knowledge of complaint investigations, risk assessment, and product quality analysis
- Understanding of FDA regulations and medical device quality systems
- Experience working with cross functional engineering and quality teams
- Bachelor's degree in Engineering or related technical field
- Ability to travel occasionally to customer sites (up to 25 percent)