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Akkodis · 22 hours ago

Product Quality Engineer

Arden Hills, MN

Contract

Onsite

Entry, Mid Level

$30/hr - $35/hr

1+ years exp

Akkodis is seeking a Product Quality Engineer for a 12-month contract position. The role involves reviewing product complaints, performing investigations, analyzing data, and communicating product performance while contributing to process improvements and project management in the medical device manufacturing industry.

Information Technology & Services

H1B Sponsor Likely

Hiring Manager

Akash Jaiswal

Responsibilities

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

Qualification

Medical device experienceData analysisQuality system processesTechnical writingProject managementStatistical methodsCommunication skillsTeam collaboration

Required

BS with 1-3 years of relevant experience

A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems

Understanding and a command of highly technical engineering topics and applied statistics

Ability to independently manage project work to define and consistently meet delivery dates

Understanding and experience operating within quality system processes and procedures

Strengths in communication (verbal and written) and data analysis skills

Preferred

Engineering Degree with 2+ years of relevant medical device experience

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

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

Akkodis 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

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Trends of Total Sponsorships

2025 (141)

2024 (121)

2023 (67)