Senior Supplier Quality Engineer – Supplier Qualification & Validation

Job description

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. 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. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.