Quality Engineer

Insight Global

Arden Hills, MNJobNo compensation foundTracked 4w agoSeen in employer's feed 5 days ago

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At a glance

Compensation

No compensation found

Location

Arden Hills, MN

Work Authorization

Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Insight Global is hiring a Quality Engineer. The Quality Engineer monitors product performance, investigates customer complaints, and analyzes post-market surveillance data to identify trends, risks, and improvement opportunities. This role involves collaborating with cross-functional teams to assess field performance, support risk management, and ensure patient safety. The engineer conducts complaint investigations, reviews returned product analyses, performs data-driven evaluations, and communicates findings to stakeholders. They also assist with electronic circuit investigations and drive continuous process improvements in a regulated medical device environment.

Key focus areas include Monitor product performance, Investigate customer complaints, and Analyze post-market surveillance data to identify trends, risks, and opportunities for product improvement.

Successful candidates bring Electrical Background, Bachelor's Degree In EE Or Biomed, and Engineering Degree. Important skills include Monitoring Product Performance, Investigating Customer Complaints, Analyzing Post-Market Surveillance Data, Identifying Trends, Identifying Risks, and Identifying Opportunities For Product Improvement.

Skills & qualifications

RequiredNice to have

Skills

Monitoring Product PerformanceInvestigating Customer ComplaintsAnalyzing Post-Market Surveillance DataIdentifying TrendsIdentifying RisksIdentifying Opportunities for Product ImprovementAssessing Field Performance SignalsSupporting Risk Management ActivitiesEnsuring Patient SafetyConducting Complaint InvestigationsReviewing Returned Product AnalysesPerforming Data-Driven Evaluations Using Statistical MethodsSupporting Regulatory RequestsCommunicating Product Performance FindingsAssisting With Electronic Circuit and Component InvestigationsCollaborating With Lab Technicians on Product EvaluationsDriving Continuous Process ImprovementsElectrical BackgroundInvestigating Electronic Circuits and ComponentsReviewing Electronic Circuits and ComponentsUnderstanding of Highly Technical Engineering TopicsStatisticsIndependently Manage Project WorkDefining Delivery DatesConsistently Meeting Delivery DatesUnderstanding Quality System Processes and ProceduresPhysical Device AnalysisTechnical Understanding of Medical Device Therapy ProductsHazard Analysis and Risk AssessmentTrend ManagementQuality System EscalationsCAPA InvestigationsField AssessmentsMedical Device Regulatory Requirements of Post-Market Complaint TrackingProject ExperienceCollaboration With Medical SafetyCollaboration With Design AssuranceCollaboration With Return Product AnalysisCollaboration With Supplier DevelopmentCollaboration With Manufacturing

Qualifications

Bachelor's Degree in EE or Biomed2-3 Years of Relevant Medical Device Experience

Full job description

Job Description

This person will be responsible for monitoring product performance, investigating customer complaints, and analyzing post-market surveillance data to identify trends, risks, and opportunities for product improvement. They will partner with cross-functional teams to assess field performance signals, support risk management activities, and ensure patient safety. They will conduct complaint investigations, reviews returned product analyses, performs data-driven evaluations using statistical methods, supports regulatory requests, and communicates product performance findings to stakeholders. This person will assist with electronic circuit and component investigations, collaborates with lab technicians on product evaluations, and drives continuous process improvements in a regulated medical device environment.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

Must have an electrical background.

- Experience with Investigating and/or reviewing electronic circuits and components.

- Bachelor's degree in EE or Biomed

- 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. • Engineering Degree with 2-3 years of relevant medical device experience.

Experience in physical device analysis.
Strong technical understanding of medical device therapy products.
Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
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.

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