Supplier Quality Engineer

The Supplier Quality Engineer (SQE) is responsible for ensuring that purchased materials, components, and services consistently meet quality, regulatory, and performance requirements (e.g., ISO 9001, ISO 13485, 21 CFR Part 820, and other applicable regulatory standards).

The SQE role works with internal cross-functional teams (Purchasing, Engineering, Quality Assurance, and Operations) to drive supplier quality management, process improvement, and compliance initiatives by ensuring supplier’s products and services meet all of MGC Diagnostics’ specification and procedural requirements.

• 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 (Q ) 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.

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.
• 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.

Certifications
:
Certified Lead Auditor to ISO 13485

MDSAP Lead Auditor, ASQ Certified Quality Auditor

• Strong interpersonal, communication, and negotiation skills
• Adaptable/Flexible with multiple priorities
• Ability to work autonomously and proactively in a regulated environment
• Effective with time management
• Strong attention to detail
• Ability to travel to supplier sites (10–25% as required)

This position has no supervisory responsibilities.

• Will be required to regularly stand for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see.
• Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms.
• Requires repetitive…