Staff Supplier Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, take ownership of, and continuously enhance a global 3PL Quality Management Program.

• Establish qualification frameworks, quality agreements, and re-evaluation processes for 3PL providers and logistics vendors.

• Drive the global harmonization of 3PL quality controls, distribution oversight, and logistics quality standards.

• Maintain quality oversight for storage validation, environmental monitoring, product handling, serialized inventory, labeling/repackaging, and transportation controls.

• Lead risk-based audits of 3PL providers, distribution centers, and service suppliers.

• Create and manage audit schedules, risk models, protocols, checklists, and reporting templates.

• Conduct audits in compliance with GDP, ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 requirements.

• Evaluate audit findings, generate audit reports, facilitate root-cause analysis, and oversee SCAR/CAPA reviews and effectiveness verification.

• Spearhead strategic quality engineering initiatives and continuous process improvement projects.

• Enhance QMS software platforms that support 3PL quality workflows, audit scheduling, and SCAR tracking.

• Establish and analyze quality metrics, trends, and KPIs.

• Manage process nonconformances and CAPAs associated with 3PL, logistics, and supply-chain audit procedures.

• Oversee 3PL Supplier Corrective Action Requests from initiation to closure.

• Support governance of the Approved Supplier List.

• Maintain supplier records, audit documentation, certifications, quality agreements, and ARFs in Trackwise, SAP, and Agile.

• Act as a subject matter expert during FDA inspections, Notified Body audits, and internal QMS audits.

• Determine methods and procedures for complex assignments with minimal supervision.

• Mentor, coach, and guide junior compliance and supplier quality engineering personnel; may supervise or mentor junior staff.

⛳️ Requirements

• Expert-level knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and Good Distribution Practice (GDP/GMP) regulations.

• Proven track record in leading quality oversight and audits of global 3PLs, cold-chain storage, distribution networks, and service suppliers.

• Lead Auditor certification, such as ISO 13485 Lead Auditor or ASQ CQA.

• Demonstrated experience conducting multi-site external audits on a global scale.

• Expert proficiency with Trackwise, SAP, and Agile software platforms.

• Strong understanding of ISO 14971 risk management principles.

• Bachelor's degree in Engineering, Life Sciences, Supply Chain Management, or a related technical field is preferred.

• At least 12 years of relevant experience with a Bachelor's degree; or 8 years with a Master's degree; or 5 years with a PhD; or equivalent demonstrated experience.

• Significant experience in a high-volume, globally distributed medical device or GxP-regulated organization.

• Preferred experience in auditing global 3PL providers, temperature-controlled distribution, and international supply chain logistics within a regulated medical device setting.

• Exposure to auditing service suppliers and distributors in a regulated medical device context.

• Ability to meet applicable export-control requirements.

• Current proof of vaccination may be required for specific diseases, including COVID-19.

🏝️ Benefits

• Remote work arrangement; employees are expected to come onsite when requested by management.

• Competitive base salary, incentives, benefits, and equity options.

• Potential support for vaccination coverage/requirements as applicable to the position.

• Reasonable accommodations provided during the application and interview process.

• Commitment to equal employment opportunities and anti-discrimination protections.