21 Cfr 820 Jobs

AbbVie’s Product Development team is hiring a Systems Engineer to own DHF management and ensure traceable, audit-ready design control documentation for on-market medical devices and combination products.

Lead and grow a systems engineering team at AbbVie to manage DHFs, ensure design control compliance, and drive continuous improvement for medical devices and combination products.

Experienced Validation Engineer needed to lead software-focused V&V projects for medical devices, author protocols, and drive process improvements across cross-functional teams.

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.

Experienced document control professional needed to own DMS maintenance, ensure regulatory-compliant records, and support audits for a remote, regulated-healthcare-focused company.

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.

VahatiCor is hiring a hands-on Quality Engineer with direct catheter device experience and ISO 13485 expertise to lead quality activities for catheter manufacturing and validation.

Lead validation and qualification efforts at Gerresheimer’s Peachtree City facility to ensure compliant, well-documented manufacturing and support processes for pharmaceutical and medical device products.

Lead systems-level solutions and sustaining engineering at Insulet as a Principal Systems Engineer, providing technical leadership across design, post-market support, and regulatory-compliant lifecycle activities.

Experienced systems engineering leader needed to drive sustaining engineering, root-cause resolution, and regulatory-compliant product improvements for Insulet's wearable drug-delivery platform in a hybrid Massachusetts role.

Lead opto-mechanical engineering for ophthalmic diagnostic and visualization devices at Alcon's Lake Forest R&D site, driving high-precision designs, validation, and transition to manufacturing.

Lead and develop a Quality Engineering team in Abbott’s Electrophysiology division to drive manufacturing quality, regulatory compliance, and continuous improvement for Class II/III medical devices.

Intuitive seeks a senior Supplier Manufacturing Engineer (Plastics or Machining) to lead supplier qualification, DFM, and process controls for mission-critical components used in robotic-assisted surgery.

Lead technical project delivery and regulatory-compliant documentation for Oura's SaMD products, coordinating cross-functional teams to meet safety, quality, and regulatory requirements.

Experienced process engineer needed to lead development, validation, and scale-up of manufacturing processes for Cresilon’s hemostatic medical devices at the Brooklyn facility.