Supplier Quality Engineer

Overview

We are seeking a Senior Supplier Quality Engineer to join our Supplier Quality Engineering team as a consultant. The role is within the Medical Devices / Orthopedics manufacturing domain, supporting external manufacturing suppliers and ensuring compliance with quality, regulatory, and process standards. The ideal candidate will have strong experience in supplier quality assurance, process validation, and risk management in a regulated environment.

• Lead supplier quality assurance activities for external manufacturing suppliers producing company products.
• Own supplier approval and qualification processes, including audits and quality system assessments.
• Drive supplier development initiatives to improve process robustness, capability, and inspection readiness.
• Manage supplier change control, including supplier process changes, transfers, and equivalency evaluations.
• Plan and execute supplier validation and approval activities aligned with internal procedures and regulatory expectations.
• Apply and reinforce GMP and ISO-based standards in daily supplier quality operations.
• Provide end-to-end project management for supplier and part qualification activities (planning, scheduling, tracking, execution, and delivery).
• Identify, assess, and mitigate supplier quality risks; escalate issues early with mitigation actions.
• Partner with cross-functional teams such as R&D, Manufacturing, Quality, and Inspection Systems to support supplier decisions and continuous improvement.
• Ensure compliance with FDA, ISO, and applicable regulatory standards.

• Experience working with external vendors / manufacturing suppliers
• Strong background in Supplier Quality Assurance
• Hands-on experience in Supplier Qualification and Onboarding
• Experience managing supplier risk and quality issues
• Knowledge of Process Validation (IQ, OQ, PQ) and Process Verification
• Experience coordinating with cross-functional internal teams and external suppliers
• Minimum 5 years of experience in medical device or pharmaceutical industry
• Strong understanding of FDA and ISO regulations (FDA CFR Part 820, ISO 13485, ISO 14971)
• Six Sigma, Lean, or Lead Auditor certification is a plus
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills
• Strong organizational and planning abilities
• Ability to work independently and manage multiple priorities
• Willingness to work with offshore teams and across time zones
• Ability to handle conflicts and drive resolution