Strategic Supplier Quality Engineer Lead

Insight Global (United States); Livingston (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Insight Global is seeking a Supplier Quality Engineer Lead to govern supplier qualification, audits, and regulatory interactions across high-risk suppliers. You will own the supplier quality strategy and mentor a team of SQEs while partnering with Procurement, Operations, and Engineering.

Responsibilities include leading global audit programs, CAPA/SCAR management, supplier development, and ensuring QMS compliance. Strong leadership and regulatory knowledge are essential.

Qualifications

• Expert knowledge of FDA QSR (21 CFR 820) and regulatory expectations.
• Demonstrated leadership in supplier quality governance, audits, CAPA/SCAR, and risk management.
• Advanced problem-solving and quality tool expertise (RCA, FMEA, statistical analysis).
• Executive-level communication with internal leadership and suppliers.

Responsibilities

• Define and lead supplier quality strategy aligned with business objectives and regulatory requirements.
• Provide functional leadership and mentoring to Supplier Quality Engineers.
• Serve as escalation point for supplier quality issues and risk, including for regulatory inspections.
• Influence senior leadership decisions related to supplier risk, sourcing strategy, and business continuity.
• Lead planning and execution of global supplier audits (onsite, remote, desktop).
• Ensure escalation and closure of audit findings and compliance gaps.
• Act as primary Quality representative for supplier-related regulatory inspections and health authority inquiries.
• Establish risk classification, risk assessment, and mitigation frameworks.
• Review and present supplier performance metrics and risk data to management and senior leadership.
• Ensure proactive identification of systemic supplier risks and continuous monitoring of supplier health.
• Provide escalation leadership for SCARs and NCMRs; ensure robust root cause and sustained effectiveness.
• Lead supplier-related SCNs and change impact assessments.
• Lead supplier development initiatives focused on quality improvement and resiliency.
• Support NPI, supplier transfers, localization, and dual-sourcing.
• Provide quality leadership for supplier-facing validation activities (IQ/OQ/PQ, PPAP).
• Develop and maintain governance of Supplier Quality Agreements, SOPs, workflows, and metrics.
• Ensure supplier documentation remains compliant with QMS and regulatory expectations.
• Drive cross-functional alignment across the supplier lifecycle from selection to post-market support.

Skills

FDA QSR knowledge (21 CFR 820)

ISO 13485

EU MDR

ISO 14971

Leadership

CAPA/SCAR

RCA

FMEA

Statistical analysis

Executive communication

MS Office

Minitab

ERP systems

eQMS platforms

Tools

MS Office

Minitab

ERP systems

eQMS platforms

Job description

Insight Global is seeking a Supplier Quality Engineer Lead to govern supplier qualification, audits, and regulatory interactions across high-risk suppliers. You will own the supplier quality strategy and mentor a team of SQEs while partnering with Procurement, Operations, and Engineering.

Responsibilities include leading global audit programs, CAPA/SCAR management, supplier development, and ensuring QMS compliance. Strong leadership and regulatory knowledge are essential.