MGC Diagnostics · 15 hours ago
Supplier Quality Engineer
Twin Cities Area
Full-time
Onsite
Mid, Senior Level
$85K/yr - $104K/yr
3+ years expMGC Diagnostics is a company focused on ensuring quality in medical devices. The Supplier Quality Engineer (SQE) is responsible for managing supplier quality, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to improve supplier performance.
Health CareHealth DiagnosticsMedicalMedical Device
Hiring Manager
Jordan Ochoa
Responsibilities
Collaborate with Purchasing in supplier selection, evaluation and monitoring new and existing suppliers
Review the supplier’s QMS to ensure it can meet MGC’s ability to meet all applicable standards and regulatory requirements
Liaise with Engineering and Purchasing to establish the risk level of purchased materials or services
Monitor and update the Approved Supplier List (ASL) as needed
Manage, monitor, and perform supplier audit per the audit schedule (e.g., onsite, desktop, accreditations, and CE Certificates, Supplier Quality Agreements)
Conduct investigations driven from complaints that are related to supplier quality issues
Maintain relationships with suppliers
Leads quality related discussions, provides support in continuous improvement initiatives at supplier sites
Manage and monitors Supplier Corrective Actions (SCARs)
Support Supplier Management in defining incoming inspection requirements, guidance with qualification of materials or 1st article inspections, and supplier issues identified in the manufacturing process
Manage, assess, and approve supplier change notifications with support from Engineering and Purchasing
Maintain supplier quality documentation and records according to MGC’s QMS requirements
Support the Purchasing team with supplier Quarterly Business Reviews (QBR) by providing quality data
Supports and prepares slides on supplier quality for Quality Management Review (QMR)
Support the Quality System Manager during external audits
Other duties as assigned
Qualification
Required
Bachelor's degree in engineering, quality, or related technical discipline (Mechanical, Electrical, Industrial preferred) with a minimum of 3-5 years of experience, or a minimum of 7 years of experience in supplier quality, manufacturing quality, or related engineering role within a medical device or other regulated industry
Conduct desktop, onsite, or for cause supplier quality audits as part of the supplier monitoring and evaluation process
Experience with supplier audits, root cause analysis, CAPA, and statistical analysis
Strong knowledge of quality systems and standards (ISO 9001, ISO 13485, or FDA QSR, MDSAP, EUMDR, UKCA, depending on industry)
Proficiency in problem-solving methodologies such as 5 why's, Is/Is not, Fishbone analysis, or 8D used to complete investigations resulting from customer complaints, supplier corrective actions and non-conformances raised in production
Knowledge and experience in process verification/validation
Microsoft Office Suite, Vizio, Adobe Forms
Strong experience in QMS improvements, identifying gaps in supplier management processes, and other QMS areas related to supplier quality
Ability to coach and/or mentor on supplier or material related issues or improvements within other departments
Certified Lead Auditor to ISO 13485
Preferred
MDSAP Lead Auditor
ASQ Certified Quality Auditor
Company
MGC Diagnostics
MGC Diagnostics develops non-invasive diagnostic systems for detecting and managing cardiorespiratory disease.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-29Acquired
2003-01-17IPO
Leadership Team
Lew Schildkraut
Chief Financial Officer
Recent News
Research and Markets
2025-04-08
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