Post Market /CAPA Quality Engineer

REQ Solutions; Saint Paul (MN); Hybride; USD 70 000 - 85 000; Plein temps

Résumé du poste

REQ Solutions is hiring for a Hybrid Role in Saint Paul, Minnesota, focusing on product performance and client monitoring. The successful candidate will conduct investigations on product complaints, analyze post-market data, and support quality system processes. A relevant BS degree with 1-3 years of experience is required, preferably in engineering or medical devices. Strong communication and data analysis skills are crucial. This role offers the chance to engage in cross-functional collaboration and process improvements.

Qualifications

• 1-3 years of experience, preferably in engineering or medical devices.
• Strength in understanding technical engineering topics and applied statistics.
• Experience with quality system processes and procedures.

Responsabilités

• Investigate product complaints and monitor client product performance.
• Analyze post-market surveillance data for patterns and trends.
• Communicate product performance through formal presentations.

Connaissances

Data analysis skills

Communication (verbal and written)

Technical understanding of medical device therapy products

Formation

BS in relevant field

Description du poste

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

Education/Experience

• 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.

Preferred

• 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.