Post Market​/CAPA Quality Engineer

Hybrid Role (3 days a week) Responsibilities

• This role doesn't touch product - more data related
• This role will investigate product complaints and monitor client 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
• Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.
• May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources

• BS with 1-3 years of relevant experience.
• Candidates that thrive in this position include Biomed engineers, Math backgrounds, Chemical engineers.
• Understanding and a command of highly technical engineering topics and applied statistics.
• Understanding and experience operating within quality system processes and procedures.
• Strengths in communication (verbal and written) and data analysis skills.

• Engineering Degree with 2+ years of relevant medical device experience.
• Strong technical understanding of medical device therapy products.
• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
• Strong Technical Writing skills.
• Experience with quality system escalations, CAPA investigations and field assessments.
• Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.
• Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.