Advantage Technical ยท 1 day ago
Quality Engineer
Arden Hills, MN
Full-time
Onsite
Mid, Senior Level
$64/hr - $64/hr
4+ years expAdvantage Technical is seeking a Quality Engineer III specializing in Field CAPA and Design Quality. The role involves leading cross-functional teams to address product performance issues in the Cardiac Rhythm Management and Diagnostics division, focusing on patient safety and product quality.
Staffing & Recruiting
No H1B
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Lead cross-functional investigations for complex product performance issues where design-related root cause is suspected, including:
Nonconforming Events and Preventions (NCEPs)
Corrective and Preventive Actions (CAPAs)
Field Action recommendations, as applicable
Apply structured problem-solving methodologies such as DMAIC, Root Cause Analysis, 5 Whys, Fishbone (Cause & Effect), and Is/Is Not
Develop, maintain, and review investigation documentation in compliance with Good Documentation Practices (GDP)
Create, review, and approve Quality System records related to NCEPs and CAPAs
Present investigation status and outcomes to cross-functional partners and senior leadership
Serve as a technical consultant and mentor to engineers and cross-functional teams across projects and divisions
Partner across multiple sites and functions to define technical strategies and drive resolution of complex issues
Support Design Quality initiatives related to:
Risk management
New product development
Product sustainment
Champion continuous improvement initiatives within Design Assurance and Quality organizations
Ensure compliance with company policies, procedures, and applicable regulations
Demonstrate a strong commitment to patient safety, product quality, and regulatory compliance
Foster a diverse, inclusive, and collaborative work environment
Build quality into all aspects of work
Maintain compliance with the Quality Policy and all applicable Quality System procedures and regulatory requirements
Qualification
Required
Bachelor's degree in Engineering or a related discipline
4+ years of relevant experience in the medical device industry
Strong working knowledge of Quality System Regulations (QSR)
Strong working knowledge of Medical Device Regulations
Strong working knowledge of ISO 13485
Hands-on experience with root cause investigations
Hands-on experience with nonconforming products and processes
Hands-on experience with CAPAs and Field Action decision-making
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
Medical device experience is required
Root cause analysis and CAPA experience are required
Preferred
Experience with Active Implantable medical devices
Demonstrated strength in technical problem-solving and data analysis
Experience with statistical analysis tools (e.g., Minitab, Weibull++)
Project management experience leading direct or cross-functional teams
Ability to manage multiple projects across diverse engineering disciplines (software, hardware, labeling)
Strong communication and business acumen; able to influence at all organizational levels
Self-starter with a continuous improvement mindset
Comfortable presenting to groups, including divisional senior leadership
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase