Senior Supplier Quality Engineer jobs in United States
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Imricor · 12 hours ago

Senior Supplier Quality Engineer

Imricor Medical Systems Inc is seeking a Senior Supplier Quality Engineer to implement and maintain the supplier management program in accordance with quality management systems and medical device regulations. This role involves working with development and manufacturing teams to provide technical support for supplier selection, qualification, and performance monitoring.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Is the primary role that works with Imricor suppliers to perform supplier selection and qualification, component qualification, supplier monitoring, and supplier corrective actions
Drives supplier selection and qualification activities by interfacing with external suppliers to generate and review supplier surveys, quality agreements, nondisclosure agreements, and other supplier qualification documentation
Conducts supplier quality management system audits both virtually and in-person
Is responsible for successful completion of component qualification activities including review and development of purchased product specifications, collaboration with suppliers, determination of component qualification deliverables and acceptance criteria, and analysis of results
Develops receiving inspection plans and associated test method development activities
Monitors, analyzes, and identifies trends from supplier quality and performance data. Drives necessary supplier performance improvement
Performs analysis of purchased product nonconformances and supplier-related field quality issues. Communicates issues to suppliers and oversee subsequent corrective action implementation and evaluation
Guides organization on supplier policy by leading CAPAs and other quality system initiatives

Qualification

Supplier Quality ManagementFDA RegulationsISO 13485Microsoft OfficeQuality Systems KnowledgeEngineering DegreeSoft Skills

Required

Bachelor of Science in engineering, science, or related technical field
5+ years of Engineering and/or Quality experience
Experience with Microsoft Office: Word, Excel, PowerPoint
Knowledge of basic Quality Systems and good documentation practices

Preferred

Medical Device experience preferred
Knowledge of FDA, GMP, and ISO regulations; experience with auditing, and quality system implementation preferred
Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, and ISO 13485 preferred

Benefits

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Company

Imricor

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Imricor Medical Systems, Inc.

H1B Sponsorship

Imricor 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)

Funding

Current Stage
Public Company
Total Funding
$24.98M
2023-10-01Post Ipo Equity· $1.29M
2020-02-21Post Ipo Equity· $12.48M
2019-09-11Post Ipo Equity· $0.61M

Leadership Team

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Steve Wedan
President and CEO
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Gregg Stenzel
Chief Operating Officer
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Company data provided by crunchbase