Senior Supplier Quality Engineer – Supplier Qualification & Validation

Responsibilities

• Provides quality assurance leadership for the qualification, validation, monitoring, and development of contract manufacturing sites, raw material suppliers, and component suppliers engaged in the production of company products.
• Leads supplier selection, qualification, and onboarding activities, including supplier risk assessments, quality system evaluations, and approval of new suppliers.
• Establishes and ensures the Approved Supplier List (ASL) is maintained and up to date.
• Establishes and executes risk-based supplier audit programs and conducts supplier audits in accordance with Good Manufacturing Practices (GMP), ISO 13485, applicable regulatory requirements, and company procedures.
• Establishes comprehensive measurement systems to monitor supplier quality, reliability, delivery performance, process capability, and overall supplier effectiveness.
• Establishes and maintains Supplier Quality Agreements and associated quality requirements for applicable suppliers.
• Reports and analyzes supplier performance metrics and drives supplier improvement initiatives where required.
• Provides technical quality support to Quality Control, Purchasing, Supply Chain, Engineering, and Manufacturing departments.
• Serves as the quality lead for supplier qualification, verification, and validation activities, including review and approval of validation plans, protocols, reports, and supporting documentation.
• Ensures suppliers adequately validate manufacturing processes, inspection methods, test methods, and critical equipment, as applicable, and maintain validated status throughout the product lifecycle.
• Reviews and approves supplier validation activities including IQ, OQ, PQ, process validation, test method validation, and revalidation activities as required.
• Ensures outsourced process and product validation activities are performed, documented, and maintained in compliance with procedures, regulatory requirements, and project timelines.
• Supports new product introductions, supplier transfers, industrialization projects, and component qualification activities.
• Addresses Supplier Change Requests and evaluates associated risks, validation requirements, and regulatory impacts in compliance with procedures and applicable regulations.
• Ensures supplier nonconformances, deviations, and corrective actions are appropriately initiated, investigated, dispositioned, and closed in accordance with regulatory and company requirements.
• Reviews and approves supplier CAPA activities and verifies effectiveness of corrective actions.
• Leads root cause investigations and drives robust containment, corrective, and preventive actions for supplier-related quality issues.
• Escalates supplier quality concerns to management as appropriate and develops risk-based, compliant solutions.
• Participates in and leads continuous improvement initiatives focused on supplier quality, process performance, validation effectiveness, and supply chain robustness.
• Participates in and supports internal audits, supplier audits, customer audits, regulatory inspections, and notified body inspections.
• Manages or participates in strategic quality projects as required.
• Supports complaint investigations and field actions involving supplier-related products or components.
• Acts as a subject matter expert for supplier qualification, validation, supplier controls, and supplier quality system compliance.
• Mentors Supplier Quality Engineers and cross-functional teams on supplier quality and validation requirements.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Manufacturing, Quality, or a related technical discipline is required. Equivalent combinations of education and experience will also be considered.
• Minimum 5–8 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or Quality Systems within a regulated industry.
• Minimum 5 years of experience in a Medical Device manufacturing environment.
• Demonstrated experience in both new supplier qualification and ongoing supplier quality management.
• Strong experience with process validation, supplier validation, and component qualification activities.
• Thorough knowledge of Medical Device regulations and standards, including ISO 13485, EU MDR/MDD, and FDA 21 CFR Part 820/QMSR.
• Auditing experience is required.
• ISO 13485:2016 Lead Auditor certification strongly preferred.
• Strong knowledge of GMP requirements and risk-based quality management principles.
• Excellent communication, collaboration, organizational, and stakeholder management skills.
• Strong analytical, problem-solving, statistical analysis, and root cause investigation skills.
• Experience with process capability analysis, validation methodologies, and quality improvement tools.
• Proficiency with ERP, PLM, and Quality Management Systems.
• Proficiency with Microsoft Office applications.
• Knowledge of statistical techniques and quality engineering methods.
• Experience with machining processes, injection molding, extrusion, sterilization processes, and/or electromechanical components and assemblies preferred.
• APQP, PPAP, Design Transfer, or Supplier Development experience preferred.
• Willingness to travel internationally as required.
• Fluent in French and English.