Job Information
US Tech Solutions Quality Engineer I in St. Paul, Minnesota
$38-$45 per hour
St. Paul, MN
Full Time/Contract
Duration: 12 Months Contract (Possible Extension)
Location Onsite
Candidate will be working with 4 engineers
Candidate has to be local to MN.
Summary
The candidate will serve as a second set of eyes on complaint investigations, reviewing investigator work to ensure investigations are complete, logical, and well supported.
A successful candidate is able to analyze information critically, identify gaps or inconsistencies, and clearly communicate feedback to investigators to strengthen the overall investigation narrative and conclusions.
Job Purpose
- This 12-month contract role leads technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data to investigate and escalate issues across a range of Interventional Cardiology & Vascular Therapies (ICVT) devices.It involves cross-functional collaboration to drive product and process improvements and enhance investigation outcomes.The position also offers high visibility across site and divisional leadership.
Responsibilities:
Analyze post-market surveillance data, including customer complaints and adverse events, to ensure timely identification, investigation, and resolution of safety or quality issues in compliance with regulatory and internal standards.
Lead product signal escalations by conducting root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement.
Collaborate cross-functionally to develop and implement efficient, compliant solutions that enhance Complaint Investigation Site (CIS) processes and support organizational and regulatory goals.
Communicate product performance insights through formal presentations to leadership and design teams, support published performance reports, and respond to customer inquiries directly or via the sales organization.
Uphold a strong commitment to patient safety and product quality by ensuring adherence to the Quality Policy and all relevant procedures and standards.
Minimum Requirements:
Bachelor’s degree in engineering or a related technical or scientific discipline with 0-1 years of relevant experience
Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
Proficient in Microsoft Word, Excel, and Outlook
Apply critical thinking to ensure investigations are thorough, appropriate, and aligned with procedural and quality requirements.
Preferred Requirements:
- Experience in SAP, MES, or TrackWise
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.