Supplier Quality Engineer

Job SummaryWe 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.Roles & ResponsibilitiesLead 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.Education & ExperienceExperience working with external vendors / manufacturing suppliersStrong background in Supplier Quality AssuranceHands-on experience in Supplier Qualification and OnboardingExperience managing supplier risk and quality issuesKnowledge of Process Validation (IQ, OQ, PQ) and Process VerificationExperience coordinating with cross-functional internal teams and external suppliersMinimum 5 years of experience in medical device or pharmaceutical industryStrong understanding of FDA and ISO regulations (FDA CFR Part 820, ISO 13485, ISO 14971)Six Sigma, Lean, or Lead Auditor certification is a plusStrong analytical and problem-solving skillsExcellent verbal and written communication skillsStrong organizational and planning abilitiesAbility to work independently and manage multiple prioritiesWillingness to work with offshore teams and across time zonesAbility to handle conflicts and drive resolution