21 Cfr 820 Jobs

AbbVie is hiring a Staff Product Development Engineer to lead early-stage regenerative medicine device projects, delivering prototype design, verification, and risk-managed solutions in a regulated R&D setting.

Foresight Diagnostics is hiring an onsite QA Specialist in Boulder to maintain and advance QMS compliance (ISO 13485, 21 CFR 820, CAP/CLIA) and provide hands-on QA support to laboratory operations and process development.

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

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.

Amgen seeks an experienced Sr Data Scientist with engineering and data-engineering skills to develop AI-driven tools and data products that streamline combination product lifecycle and regulatory documentation.

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.

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.

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

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.

Insulet seeks a Project Manager, Regulatory Operations to lead regulatory intelligence coordination, document control, and cross-functional project management supporting product compliance and market authorizations.

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.

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.

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

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

Dandy is looking for a Senior Quality Engineer to lead ISO 13485 quality systems, CAPA activities, and statistical quality programs at its Carrollton manufacturing facility.

Lead the design and operation of OrganOx's QMS and document services, driving eQMS excellence, compliance, and a high-performing global team.

Intuitive seeks a Senior Quality Engineer in Peachtree Corners to lead sustaining manufacturing support, failure analysis, design control activities, and continuous quality improvements for the da Vinci Multiport service organization.

Experienced supplier-focused process engineer needed to qualify, develop, and scale electronic and electromechanical suppliers for high-volume medical device production at Intuitive.