Iso13485 Jobs

Waters Corporation is hiring an Operations Quality Engineer II to lead product and process quality initiatives at the Milford plant and GDC, driving investigations, SPC adoption, and continuous improvement.

Cresilon is hiring motivated students for a paid, 15-week onsite biotechnology internship (beginning Jan 19, 2026) across technical and non-technical tracks to work on project-based assignments supporting manufacturing, quality, R&D, data analytics, and regulatory activities.

Lead regional Quality Operations at Plexus to ensure compliance, drive APQP/FAI/PFMEA execution, reduce CoPQ and mentor teams for continuous improvement across multiple manufacturing sites.

Flex is hiring a Validation Associate Engineer in Austin to drive validation activities, maintain quality programs, and support regulatory-compliant product development in a medical device manufacturing environment.

ActiGraph is hiring a Senior Compliance Specialist to lead QMS and regulatory compliance activities across product development, post-market surveillance, and audits for their medical-grade wearable solutions.

ResMed seeks a Senior Manager of Design Quality (Digital Product) to lead a product quality team and act as the primary QA representative for software and SaMD projects, ensuring design control, risk management and regulatory compliance.

Lead device and combination product regulatory strategy and submissions at AbbVie to support timely approvals and market access.

Lead BD’s failure analysis function in Irvine to drive root-cause investigations, corrective actions, and continuous quality improvements for medical device products.

Senior QA executive needed to lead Sirtex's global quality management system, drive FDA and international regulatory approvals for device and drug products, and manage a cross-functional QA organization from the Woburn hybrid office.

Alphatec Spine is looking for a Mechanical Quality Engineer II to lead mechanical quality activities across new product development, supplier qualification, and production validation for implantable devices.

Lead full-system embedded software and hardware integration for Class III medical devices, driving real-time, bare-metal and RTOS-based design in a regulated environment.

Support Alcon’s Houston manufacturing operations as an Associate Quality Assurance Engineer on A Shift by leading inspections, audits, non-conformance resolution, and quarantine activities to ensure regulatory compliance and product quality.

Lead the development and validation of automated and manual incoming inspection methods at PROCEPT BioRobotics to ensure high-quality components for medical device manufacturing.

Lead the clinical-technology and innovation strategy to build a world-class rural health center integrating imaging-AI, surgical robotics, telehealth, and regenerative-medicine services.

Lead reagent manufacturing and quality control efforts as Director at Foresight Diagnostics, an innovative early-stage molecular diagnostics firm in Boulder, CO.