Quality Engineer I

$33-$37 per hour St. Paul, MN Full Time/Contract

• Duration:

  12 Months Contract (Possible Extension)
• Hybrid- 3 days onsite, AH.
• Prefer local candidates. Need to fill fairly quickly!

• About This Role:

• This quality engineer role will investigate product complaints and monitor 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. This role doesn't touch product - more data related responsibilities. CRM Division - currently 11 on team, very collaborative team. Guardian project related position

• Responsibilities:

• + Embodying
• Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit.

+ 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; Identifies and leads cross-functional project teams comprised of functional experts and local managers. + Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves. + Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

• Minimum requirements:
• + BS required with 1-3 years of relevant experience.

+ A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems. + Understanding and a command of highly technical engineering topics and applied statistics. + Ability to independently manage project work to define and consistently meet delivery dates. + Understanding and experience operating within quality system processes and procedures. + Strengths in communication (verbal and written) and data analysis skills.

• Preferred Qualifications
• + 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 the 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.

• About US Tech Solutions:

• US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

To learn more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.