Quality Engineer I #26-17850

US Tech Solutions, Inc.

St. Paul, MN

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JOB DETAILS

SKILLS

Analysis Skills, Biomedical Engineering, Biomedicine, Circuit Components, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer/Client Research, Data Analysis, Diversity, Documentation, Electrical Engineering, Electricity, Electronic Circuit, Hazard Analysis, Laboratory, Laboratory Analysis, Manufacturing, Market Analysis, Market Tracking, Market Trend Analysis, Medical Equipment, Medical Products, Medical Treatment, Patient Safety, Performance Analysis, Performance Management, Process Improvement, Product Documentation, Product Reviews, Product Safety, Product Support, Project Planning, Quality Engineering, Regulatory Requirements, Request for Information (RFI), Risk Analysis, Risk Management, Sales, Statistics Software, Support Documentation, Surveillance, Team Lead/Manager, Technical Writing, Trend Analysis, Vendor/Supplier Evaluation, Writing Skills

LOCATION

St. Paul, MN

POSTED

Today

Duration: 12 Months Contract

Hybrid position - 3 days (T, W, & TH) onsite, AH

Must Haves:

Must have an electrical background!
Experience with Investigating and/or reviewing electronic circuits and components.
Bachelor's degree in EE or Biomed

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.

Your Responsibilities may Include:

Embodying clients*** 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.
Investigates and reviews electronic circuits and components.
Analyzes returned products to address complaints.
Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation.
Review completed product analysis to ensure field allegations are adequately addressed.

Minimum Qualifications

Bachelor’s degree or higher in Electrical or Biomedical Engineering
BS with 1-3 years of relevant experience.
** Must have an electrical background!

Preferred Qualifications

Engineering Degree with 2-3 years of relevant medical device experience.
Experience in physical device analysis.
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 know 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

Quality Engineer I #26-17850

US Tech Solutions, Inc.

St. Paul, MN

About the Company

US Tech Solutions, Inc.

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