Advantage Technical · 1 day ago
Quality Engineer III
Twin Cities Area
Contract
Onsite
Mid, Senior Level
$64/hr - $64/hr
4+ years expAdvantage Technical is seeking a Quality Engineer III who will serve as a key leader within the Field CAPA and Design Quality team. The role involves driving cross-functional investigations to identify root causes and implement solutions for product performance issues in the Cardiac Rhythm Management and Diagnostics division.
Staffing & Recruiting
Hiring Manager
Bill Sunderland
Responsibilities
Lead cross‑functional teams on complex product performance investigations where product design is the suspected root cause, including NCEPs, CAPAs, and Field Action recommendations
Drive collaborative problem‑solving using structured methodologies such as DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagrams, and Is/Is Not analysis
Build, maintain, and strengthen cross‑functional partnerships across multiple sites; provide guidance on technical strategies and issue resolution
Represent the team in global and divisional leadership forums
Create and maintain detailed investigation documentation in accordance with Good Documentation Practices
Create, review, and approve Quality System records for NCEPs and CAPAs
Present investigation updates in both formal and informal settings, including to senior leadership
Mentor and guide engineers and cross‑functional teams on NCEP and CAPA execution, potentially across multiple divisions
Champion continuous improvement initiatives within local and divisional Design Assurance organizations
Promote a diverse and inclusive work environment that enables all contributors to reach their full potential
Ensure compliance with company policies, procedures, and Quality System requirements
Demonstrate a strong commitment to patient safety and product quality
Build quality into all aspects of work by maintaining compliance with all quality requirements
Adhere to the Quality Policy and all documented quality processes and procedures
Qualification
Required
Bachelor's degree in engineering or a related discipline, plus 4+ years of relevant experience
Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485
Experience in the medical device industry
Experience with non‑conforming products/processes, CAPAs, Field Action decision‑making, and investigation processes
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)
Preferred
Experience with active implantable medical technologies
Strong technical problem‑solving and data analysis skills
Experience with statistical tools (e.g., MINITAB, Weibull++)
Ability to multi‑task effectively and adapt to changing priorities
Project management experience (direct or cross‑functional)
Strong business acumen and communication skills, with the ability to articulate impact and consequences
Ability to collaborate and influence across diverse, cross‑functional teams
Experience leading multiple projects across engineering disciplines (Software, Hardware, Labeling, etc.)
Self‑starter with a track record of identifying improvement opportunities
Comfortable presenting to groups, including senior divisional leadership
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase