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 The Associate Quality Manager is responsible for developing implementing and maintaining the Quality Management System QMS to ensure compliance with applicable medical device regulations and standards in a hybrid operational model This role will support commercial direct sales distribution channels and service repair operations Key Responsibilities Quality Management System OversightMaintain and continuously improve the QMS in accordance with ISO 13485 FDA 21 CFR Part 820 MDR IVDR and other regional regulations Lead internal audits management reviews and compliance readiness activities Develop and implement policies SOPs and work instructions supporting hybrid and distributed teams Commercial Distribution QualityEnsure quality compliance for direct market sales including product release complaint handling and field performance monitoring Evaluate qualify and audit distributors and third-party logistics partners Establish quality agreements and monitor supplier distributor performance indicators Oversee product labeling storage conditions and traceability through the supply chain Service Repair Quality ManagementOversee quality controls for service centers in-house repair and field service activities Ensure service technicians follow approved procedures calibration standards and documentation practices Support product returns RMA investigation processes and repair validations Implement quality measures to ensure repair effectiveness and minimize recurring issues Nonconformance CAPA ManagementLead root-cause investigations for product nonconformances service failures distribution issues and customer complaints Manage the CAPA system program to ensure timely and effective corrective and preventive actions Track quality trends using statistical methods to drive continuous improvement Complaint Handling Post-Market SurveillanceOversee complaint intake and coordination with the complaints handling unit Management and coordination of recall management Training Cross-Functional CollaborationProvide training on QMS processes regulatory requirements and quality best practices to internal teams and external partners Work closely with commercial distribution operations engineering and service repair departments to maintain alignment Ensure quality requirements are integrated into product updates service protocols and distribution workflows Documentation ReportingManage controlled documentation in accordance with regulatory and QMS requirements Prepare quality metrics dashboards management review reports product quality summaries and audit findings Ensure accurate recordkeeping across hybrid teams including remote service technicians and distribution partners Qualifications RequiredBachelor s degree in Engineering Life Sciences Quality or a related field with 8 years of quality assurance experience in the medical device industry OR Master s degree in Engineering Life Sciences Quality or a related field with 5 years of quality assurance experience in the medical device industry Strong knowledge of ISO 13485 FDA QSR global medical device regulations and QMS principles Experience supporting distribution networks and or service repair operations Proven ability to manage audits CAPA nonconformances and complaint investigations Strong analytical communication and project management skills PreferredASQ CQE CQA or similar certification Experience with EU MDR CMDR and APAC regulations Experience with ERP and electronic QMS systems e g Oracle Agile TrackWise Experience with risk management per ISO 14971 CompetenciesDetail-oriented with strong regulatory discipline Ability to collaborate across multiple functional levels and external partners Problem-solving and root-cause analysis expertise Ability to manage multiple priorities in a dynamic commercial and service setting 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