Senior Quality Assurance Manager

Job Title: Sr. Manager, Supplier Quality Management

Location: [Livingston, NJ OR Trumbull, CT - 5 days a week on site]

Position Overview

We are seeking a dynamic and experienced Sr. Manager, Supplier Quality Management to lead our global Supplier Quality team. This strategic role is responsible for overseeing the quality performance and compliance of suppliers and service providers involved in the manufacture and service of finished goods, components, materials, and logistics across a global supply chain. The ideal candidate brings deep expertise in both medical device and pharmaceutical quality systems and has a strong command of 21 CFR Part 820, Part 211, ISO 13485, EU MDR 2017/745, and MDSAP standards.

Key Responsibilities

Lead and manage a global team of Supplier Quality professionals, ensuring alignment with corporate priorities and business needs.

Develop and execute a comprehensive supplier quality strategy encompassing supplier selection, qualification, approval, re-evaluation, auditing, and performance monitoring.

Drive standardization and continuous improvement of supplier quality systems across all facilities in compliance with global regulatory requirements.

Establish and maintain SOPs and ensure alignment with corporate quality policies and Good Manufacturing Practices (GMP).

Serve as a key representative of Supplier Quality Assurance in cross-functional meetings and initiatives.

Monitor supplier performance and lead resolution of quality issues, including complaint investigations, non-conformances, CAPAs, and root cause analysis.

Manage and review supplier quality agreements, audit schedules, and change notifications.

Support internal and external audits, including FDA inspections and notified body assessments, acting as a Subject Matter Expert (SME) for supplier quality.

Provide ongoing coaching, development, and performance management for direct reports, fostering a culture of quality, accountability, and excellence.

Collaborate with IT, Quality, and Operations to develop and implement digital solutions for quality system enhancements.

Contribute to the Global Quality Management strategic planning and budgeting processes.

Qualifications

Bachelor’s Degree in Engineering or related technical discipline required; advanced degree preferred.

Minimum of 10 years of experience in medical device and/or pharmaceutical industries, with strong knowledge of 21 CFR Part 820, 21 CFR Part 211, ISO 13485:2016, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP.

At least 5 years of leadership experience managing quality teams, including remote or global team members.

Certified Lead Auditor with proficiency in PPAP, CAPA, auditing, and quality agreements.

Demonstrated experience working with shared global quality systems.

Proficient in MasterControl, ComplianceWire, and other eQMS/LMS systems.

Advanced knowledge of Microsoft Office Suite and project management tools including Smartsheet, Teams, and Access.

Strong communication and cross-functional collaboration skills.

Experience in managing supplier quality in both regulated medical device and pharmaceutical environments is strongly preferred.