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Akkodis · 1 day ago

Quality Engineer

Arden Hills, MN

Contract

Onsite

Mid, Senior Level

$60/hr - $65/hr

4+ years exp

Akkodis is seeking a Quality Engineer for a 12+ Contract position. The role involves leading cross-functional teams to investigate product performance issues and implementing effective solutions within the Cardiac Rhythm Management and Diagnostics division.

Information Technology & Services

H1B Sponsor Likely

Responsibilities

Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable

Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not

Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. Represents the team at key global and divisional leadership forums

Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines

Creates, reviews, and approves Quality System records for NCEPs and CAPAs

Presents updates in formal and informal reviews with all levels of the organization including high senior leadership

Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs

Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations

Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives

Monitors and ensures compliance with company policies and procedures

Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the

Qualification

Quality System RegulationsMedical Device RegulationISO 13485 StandardsTechnical problem-solvingData analysisStatistics toolsActive Implantable technologiesProject managementMicrosoft OfficeContinuous improvementCross-functional collaboration

Required

Bachelor's degree in an engineering or related discipline, plus 4+ years of relevant experience

Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards

Experience in Medical Device industry

Experience with non-conforming products/processes, CAPAs, Field Action decision making and other investigation processes

Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook

Experience with Active Implantable medical technologies

Demonstrated technical problem-solving & data analysis capabilities

Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)

Project management experience (direct or cross-functional teams)

Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions

Benefits

Medical

Dental

Vision

Life insurance

Short-term disability

Additional voluntary benefits

An EAP program

Commuter benefits

401K plan

Paid Sick Leave

Holiday pay

Company

Akkodis

Glassdoor3.3

Akkodis provides digital engineering solutions for sustainable and innovative industries.

Zug, Zug, CHE

10001+ employees

https://www.akkodis.com

H1B Sponsorship

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