Supplier Quality Engineer II

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.

• Lead qualification, selection, approval, and requalification activities for suppliers, contract manufacturers, and special process providers using risk-based methodologies.
• Perform supplier risk assessments and establish supplier classification strategies based on product impact, process criticality, and regulatory requirements.
• Ensure maintenance of the Approved Supplier List (ASL) and supplier qualification records.
• Establish, review, and maintain Supplier Quality Agreements and other quality-related contracts.
• Conduct supplier evaluations and periodic reviews to ensure continued suitability and compliance.

• Develop, monitor, and report supplier quality metrics, including nonconformance rates, CAPA effectiveness, audit results, delivery performance, and complaint trends.
• Analyze supplier quality data and identify emerging risks through statistical and trend analysis.
• Lead supplier performance reviews and quality business reviews.
• Develop and implement supplier improvement plans to enhance quality, process capability, compliance, and operational performance.

• Plan, conduct, and document supplier audits in accordance with internal procedures, ISO 13485 requirements, and applicable regulatory standards.
• Assess supplier quality systems, manufacturing controls, validation programs, risk management practices, and compliance with applicable regulations.
• Verify implementation and effectiveness of supplier corrective actions resulting from audits or quality events.
• Support qualification and oversight of critical suppliers and contract manufacturers.

• Lead investigation and resolution of supplier-related nonconformances, deviations, complaints, and quality events.
• Facilitate root cause investigations using structured problem-solving methodologies such as 8D, Fishbone Analysis, 5-Why Analysis, and Failure Analysis.
• Ensure timely implementation and verification of corrective and preventive actions.
• Assess effectiveness of implemented actions and drive continuous improvement initiatives.

• Review and approve supplier change notifications and supplier change requests.
• Evaluate changes for potential impact to product quality, patient safety, process validation, risk files, manufacturing processes, regulatory submissions, and product performance.
• Participate in cross-functional change control activities and ensure appropriate validation and regulatory assessments are completed prior to implementation.

• Support qualification and validation of supplier manufacturing processes, special processes, equipment, software, and test methods.
• Review validation documentation including IQ, OQ, PQ, process capability studies, and statistical analyses.
• Provide technical support for manufacturing transfers involving suppliers and contract manufacturers.
• Ensure outsourced processes remain validated and compliant throughout their lifecycle.

• Support product and process risk management activities in accordance with applicable risk management requirements.
• Participate in risk assessments related to suppliers, manufacturing processes, materials, and components.
• Ensure supplier-related risks are appropriately evaluated, mitigated, documented, and periodically reviewed.
• Drive risk-based decision making throughout supplier quality processes.

• Serve as Subject Matter Expert for supplier controls during internal audits, customer audits, notified body audits, and regulatory inspections.
• Support responses to audit observations, regulatory findings, and supplier-related compliance issues.
• Provide documentation and objective evidence demonstrating effective supplier controls.
• Ensure supplier quality processes remain compliant with global regulatory requirements.

• Champion continuous improvement initiatives that improve supplier quality, compliance, process capability, and business performance.
• Apply quality engineering principles and statistical methods to drive process improvements.
• Identify opportunities to reduce supplier-related risks, nonconformances, and quality costs.
• Partner with suppliers to implement sustainable quality improvements and best practices.

• Bachelor's degree in Engineering, Life Sciences, Quality, Manufacturing, or related technical discipline required.
• Advanced degree preferred.

• Minimum 3-5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Engineering, or Quality Assurance within a regulated industry.
• Medical device industry experience preferred.
• Experience working with contract manufacturers and critical suppliers preferred.
• Experience conducting supplier audits and leading supplier quality improvement initiatives.
• Fluent in French and English .

• Thorough understanding of ISO 13485 requirements and quality management systems.
• Working knowledge of FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820 and other applicable global regulations.
• Knowledge of supplier controls, process validation, risk management, CAPA, nonconformance management, and change control systems.
• Experience with quality engineering tools including: Root Cause Analysis8D MethodologyFailure Mode and Effects Analysis (FMEA)Statistical Process Control (SPC)Measurement System Analysis (MSA)Process Capability AnalysisControl PlansSampling Plans and Acceptance Activities
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• Ability to effectively interact with suppliers and cross-functional teams globally.

• Ability to travel domestically and internationally as required to support supplier qualification, audits, investigations, and business needs.
• Travel requirement may vary based on supplier portfolio and business priorities.

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.