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Company

Original Job Post

Stereotaxis · 6 days ago

Quality Engineer II

Greater St. Louis

Full-time

Onsite

Mid Level

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Hiring Manager

Erica McCaskey

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Responsibilities

Act as Quality Engineering representative on development teams to ensure compliance with Regulations, International Standards, and internal design control system requirements.

Assist with complaint handling processes, nonconformance/deviation processes, and perform corrective and preventive action activities.

Support risk analysis activities (i.e., risk mgmt. planning, FMEAs, Hazard Analysis) as required to support product development activities.

Lead in the implementation of assurances, process controls, NCRs, and CAPA systems designed to meet or exceed internal and external requirements.

Perform DHR review/release of sterile and non-sterile products.

Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements

Evaluates mechanical product design and identifies potential design quality issues and drives technical decisions. Drives design quality, reliability, and compliance to standards and regulations.

Manages timelines for investigations to ensure that reporting is performed on time and investigations are addressed in a timely manner.

Work with process owners to create or update procedures to address quality risks.

Perform internal audits and lead on external audits as needed.

Qualification

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Quality EngineeringProduct DevelopmentDesign ControlsProcess ImprovementSupplier QualityFailure InvestigationInternational StandardsDesign Control SystemComplaint HandlingNonconformanceCorrective ActionPreventive ActionRisk AnalysisRisk ManagementFMEAsHazard Analysis21 CFR 820ISO 13485EU MDRMDSAPMechanical Product DesignInternal AuditsExternal Audits

Required

Bachelor’s degree in Engineering or related field

Minimum of 3 years of experience in Quality Engineering within a regulated industry (medical device preferred)

Experience with product development/design controls, process improvement, supplier quality, and failure investigation

Knowledge of Regulations, International Standards, and internal design control system requirements

Experience with complaint handling processes, nonconformance/deviation processes, and corrective and preventive action activities

Experience in risk analysis activities (e.g., risk management planning, FMEAs, Hazard Analysis)

Familiarity with quality system requirements such as 21 CFR 820, ISO 13485, EU MDR, and MDSAP

Ability to evaluate mechanical product design and identify design quality issues

Experience in managing investigations and ensuring timely reporting

Ability to perform internal audits and lead external audits

Company

Stereotaxis

Stereotaxis develops robotic cardiology instrument navigation systems that enhances the treatment of arrhythmias and coronary diseases.

Founded in 1990

St Louis, Missouri, USA

51-200 employees

http://www.stereotaxis.com

H1B Sponsorship

Stereotaxis 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

Trends of Total Sponsorships

2022 (1)