Iso 13485 Jobs

Lead and mentor a technical manufacturing engineering team at Intuitive to establish, validate, and improve processes for producing complex robotic surgical instruments while ensuring regulatory compliance and product quality.

Intuitive is hiring a Quality Engineer 2 to support sustaining manufacturing, design verification, and quality improvement activities for da Vinci Multiport systems in Peachtree Corners, GA.

Lead and elevate Frida’s Quality Assurance function by building and executing an ISO 13485/FDA-aligned QMS, driving supplier quality, testing, audits, and CAPA across new product development and legacy ranges.

Lead first-shift assembly operations and a team of ~50 production employees at Medtronic’s Plymouth facility to deliver safe, compliant, and efficient manufacturing for Peripheral Vascular Health products.

Lead global compliance and remediation programs at Philips to strengthen product quality, ensure regulatory compliance (EU‑MDR and FDA), and drive process standardization across manufacturing sites.

Medtronic is hiring a Design Quality Engineer II to provide design-control and risk-management engineering support for ACM medical device products, ensuring compliance with ISO13485, FDA QSR and related standards.

Experienced software engineer needed to lead development of secure C# manufacturing systems and drive cybersecurity and compliance for medical device production at iRhythm.

Medtronic Minimed Americas is hiring a Regional Distribution Quality Specialist to drive distribution quality, regulatory compliance and continuous improvement across 3PL sites in the Americas.

Lead and scale post-commercialization technical support, field service, and customer experience for Nautilus's proteomic analysis platform based in San Carlos, CA.

Medtronic is hiring a Sr. Design Quality Manager to lead a global RPE team and drive design control, change control, and risk management to keep the ACM product portfolio state-of-the-art and compliant.

Alcon seeks a Principal Engineer II, Product Certification to lead electrical safety testing, certification activities, and compliance verification for medical electrical devices at its Lake Forest R&D site.

Experienced client-facing leader needed to manage enterprise relationships, drive renewals and expansion, and translate technical quality services into business value for regulated-industry clients.

US-remote CAPA Engineer responsible for leading CAPA/NC investigations, driving corrective actions, and supporting regulatory compliance and continuous improvement across the quality system.

QRC Group is hiring a Validation Engineer to lead IQ/OQ/PQ, FAT/SAT, and cleanroom qualifications for a multi-dose preservative-free nozzle subsystem across the Southeast U.S.

A paid summer Regulatory Affairs internship at Philips San Diego providing practical experience with medical device regulatory submissions, documentation, and compliance.

An experienced engineer is sought to develop and validate software and data automation solutions for manufacturing operations at 10x Genomics' Pleasanton headquarters.

Lead and scale the quality function at an early-stage medical device company, establishing QMS, design controls, risk management, and supplier quality to support Class III product development and first-in-human trials.

An experienced ISO 13485 Lead Auditor is needed to perform MDSAP and 21 CFR Part 820 audits, lead client engagements, and mentor audit teams for a growing MedTech CRO.

Solventum seeks a Quality Engineer in Irvine to support medical device quality systems, investigations, and product compliance initiatives.

Experienced manufacturing engineer needed to perform failure analysis, improve manufacturing yields, and lead cross-functional reliability improvements for electromechanical surgical systems at a market-leading medical device company.

FUJIFILM Irvine Scientific is looking for a QA Support Specialist in Santa Ana to manage customer quality inquiries, supplier qualifications, and audit follow-up to support product and regulatory quality needs.

Cook Polymer Technology is seeking an Engineering Co-op to support manufacturing engineering projects during a paid semester assignment at its Bloomington facility.

Philips is hiring a Mechanical R&D Development Engineer to drive design changes, create CAD and design documentation, prototype components, and support medical device development and sustaining activities.

Experienced quality operations engineer needed to lead inspection, reprocessing releases, equipment event resolution, and process improvements for instrument cleaning and sterilization at Intuitive's Dallas facility.

Lead a production engineering value stream to drive safety, quality, delivery and continuous improvement for medical device manufacturing.

Experienced mechanical engineer needed to lead design controls, testing, and verification for catheter-based instruments in support of a market-leading robotic bronchoscopy platform.

Engineer I – Disposables R&D, Sustaining to support design changes, validation, and prototype development for Class II/III disposable medical devices at Vantive in Plymouth, MN.

Lead systems engineering efforts for electromechanical medical devices at Farm (a Flex company), driving requirements, architecture, risk management, integration, and test strategies.

Paid Spring 2026 Manufacturing Engineering Co-op at Cook working on production engineering, process validation and quality-focused projects in a medical device manufacturing setting.

Capricor Therapeutics is hiring a Supplier Quality Management (SQM) Supervisor to lead supplier qualification, audits, and GMP-aligned supplier programs supporting cell and exosome therapeutic development from its San Diego site.

Lead and strengthen AbbVie's device and combination product quality systems as Senior Manager, providing regulatory compliance expertise, audit leadership, and global QMS program management.

Senior Manufacturing Engineer needed at Medtronic’s Brooklyn Center facility to drive process improvements, quality, and cost reductions for injection-molded and assembly components in a regulated medical-device manufacturing environment.

Sentec is hiring a Global Complaint Resolution Manager to lead complaint handling, manage FSCA/recalls, and ensure regulatory compliance for high‑risk medical devices.

Lead quality systems and regulatory compliance for AbbVie’s medical devices and combination products, driving audits, corrective actions, and global quality improvements.

Join Dandy as a Quality Systems Specialist to maintain audit-ready QMS practices, support eQMS rollout, and ensure regulatory compliance across multi-site medical device operations.

Medtronic is seeking an experienced Principal Microbiologist to lead terminal sterilization process development, qualification, and sterility assurance for medical devices at the Los Angeles site.

Teguar is hiring a Hardware Applications Engineer to lead hands-on validation, lab and witness testing, and customer-facing technical documentation for industrial and medical computer systems.

Lead the Design for Reliability function for Philips' Image-Guided Therapy systems, driving robust product design, reliability testing, and cross-functional DFR adoption to improve patient outcomes.

Serve as the on-site Quality Assurance Engineer driving QMS compliance, audits, CAPA, and sterilization validation for a multi-site medical device manufacturer.

Lead global regulatory strategy and submissions for trauma and extremities orthopedic devices at Stryker, ensuring compliance and market access across regions.

Lead product strategy for a transplant diagnostics software platform, shaping roadmaps, interoperability, and AI-enabled solutions while partnering with clinical and cross-functional teams.

QRC Group is hiring Validation Engineers to lead IQ/OQ/PQ, FAT/SAT, cleanroom qualification, and traceability activities for a multi-dose preservative-free nozzle subsystem across the Southeastern U.S.

Experienced medical device quality engineer wanted to lead CAPA, audits, and QMS improvements for a plastic medical device manufacturer operating under FDA and ISO requirements.

Experienced electrical/hardware engineer needed to support manufacturing and sustaining engineering for Philips ultrasound systems at the Reedsville production site.

Lead BD’s Surgical Solutions PMO to execute and deliver high-impact medical device innovations from concept through global launch while mentoring technical leaders and aligning portfolio priorities with business strategy.

Experienced product development engineer needed to lead R&D projects, design control activities, and regulatory technical strategies at BD's Franklin Lakes site.

Intuitive Surgical is looking for a hands-on Mechanical Design Engineer to design electromechanical systems and prototypes that support next-generation robotic-assisted surgical platforms.

Lead and coordinate 2nd-shift assembly operations at RRD's Houston facility to ensure on-time, high-quality production while supporting ISO compliance and team development.

AbbVie’s DCPD team is hiring a Senior Project Manager to lead clinical trial readiness and cross-functional coordination for complex device and drug-delivery systems in early-stage development.

Lead engineering and manufacturing at iota Biosciences to advance Class III implantable neurodevices from pivotal trials to early commercial scale.