Quality Engineer - Medical Device

Job Title : CAPA Quality Engineer

Duration : 12+ Months (Possible temp to hire)

Location : Arden Hills, MN 55112

Hybrid Role (3 days a week)

Responsibilities :

• This role doesn't touch product - more data related
• This role will investigate product complaints and monitor BSC product performance.
• The team uses product performance data and deep dive analysis to understand if products are performing as intended.
• Escalating post-market field performance signals to better understand what the data is telling us
• Collaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance.
• Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.
• Performing complaint investigations in accordance with local and global processes.
• Analyzing post market surveillance data for patterns and trends and investigating when necessary.
• May be responsible for querying & bounding data to support implementation of document releases.
• Responding to Competent Authority Requests.
• Communicating product performance by formal presentations to management committees and design teams
• Supporting published product performance reports and customer requests for performance information either directly or through the sales organization.
• Providing input for process improvement and helping develop tactical approaches to implement team strategies

Education / Experience :

Preferred :