Supplier Quality Engineer

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

The Supplier Quality Engineer Lead governs supplier qualification, compliance, auditing, development, and escalation activities for high-risk, high-impact, and strategic suppliers. This role owns supplier quality strategy, serves as escalation point for complex supplier issues and regulatory interactions, and plays a key role in management review, audit readiness, and organizational quality maturity. The position provides leadership and mentoring to Supplier Quality Engineers and partners closely with Procurement, Operations, Engineering, Regulatory, and Business Leaders.

Essential Functions & Accountabilities:

Supplier Quality Leadership & Strategy

• 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, Risk 1 suppliers, outsourced processes, and supply chain disruptions.
• Influence senior leadership decisions related to supplier risk, sourcing strategy, and business continuity.

Supplier Audits & Regulatory Compliance

• Lead planning and execution of global supplier audit programs (onsite, remote, desktop).
• Ensure effective management, escalation, and closure of audit findings and compliance gaps.
• Act as primary Quality representative for supplier-related regulatory inspections, notified body audits, and health authority inquiries.
• Establish and oversee supplier risk classification, risk assessment, and mitigation frameworks.
• Review, trend, and present supplier performance metrics and risk data to Management Review and senior leadership.
• Ensure proactive identification of systemic supplier risks and continuous monitoring of supplier health.
• Provide oversight and escalation leadership for Supplier Corrective Action Requests (SCARs), ensuring robust root cause and sustained effectiveness.
• Lead supplier-related Nonconforming Material Reports (NCMRs) and support critical escalations.
• Evaluate and manage Supplier Change Notifications (SCNs) and change impact assessments.

Supplier Development & Continuous Improvement

• Lead supplier development initiatives focused on quality improvement, compliance, delivery performance, and resiliency.
• Support New Product Introduction (NPI), supplier transfers, localization, and dual-sourcing initiatives.
• Provide quality leadership for supplier-facing validation activities (IQ/OQ/PQ, PPAP, qualifications).

Quality Systems & Governance

• Develop, Maintain governance and continuous improvement of Supplier Quality Agreements, SOPs, workflows, and metrics.
• Ensure supplier documentation, records, and controls remain compliant with QMS and regulatory expectations.
• Drive cross-functional alignment across the supplier lifecycle from selection through post-market support.

Qualifications

Knowledge, Skills and Abilities:

• Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.
• Strong leadership experience in supplier quality governance, audits, CAPA/SCAR, and risk management.
• Demonstrated ability to lead through influence and manage complex cross-functional initiatives.
• Advanced problem-solving and quality tool expertise (RCA, FMEA, statistical analysis).
• Executive-level communication skills with internal leadership and external suppliers.
• Proficiency with MS Office, Minitab, ERP systems, and eQMS platforms.

Experience:

• Experience in Supplier/Vendor Quality Management.
• Multiple years experience in a regulated quality environment (medical device, pharma, life sciences).
• Proven leadership of high-risk suppliers, regulatory interactions, and global supplier initiatives.
• Manufacturing, clean room, warehouse, and office environments.
• May require extended periods of sitting, standing, and movement in production and supplier facilities.