21 Cfr Jobs

Support AbbVie's Worcester manufacturing operations as an Automation Engineer responsible for PLC/HMI/SCADA development, commissioning, validation and ongoing troubleshooting in a cGMP environment.

Dandy is hiring a Senior Quality Engineer to lead ISO-driven quality systems, CAPA, and validation efforts for its manufacturing operations supporting dental prosthetics and medical-device-grade processes.

Dental Insurance

Disability Insurance

Vision Insurance

Equity

Paid Time-Off

Medical Insurance

Mental Health Resources

Paid Holidays

Company Retreats

Hims & Hers is hiring an onsite Night Shift Quality Control Supervisor for its Gilbert non-sterile compounding pharmacy to lead inspections, support compliance, and coach QC staff.

Senior Director of Product Management to lead strategy and execution for patient support and engagement solutions at a healthcare-focused technology company.

Experienced statistical programming manager needed to lead SAS-based dataset and output development, QC, and CRO oversight for clinical trials at REGENXBIO in Rockville, MD.

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.

Lead and manage Business Development Operations for a technology-enabled CRO, overseeing proposals, contracts, forecasting, and cross-functional coordination to drive responsive, high-quality client engagements.

Join Intuitive as a Post Market Surveillance Adverse Event Analyst to investigate serious device-related complaints, make regulatory reporting decisions, and drive complaint lifecycle closure for a market-leading medical device company.

Moderna is hiring an Associate Director in R&D Quality to lead vendor quality agreements, metrics, audits, and CAPA activities to enhance vendor oversight and inspection readiness.

Bristol Myers Squibb is hiring a Senior Engineer for IT Computer System Validation at the Devens Cell Therapy Facility to lead CSV lifecycle activities, act as a CSV SME, and ensure computerized systems meet GxP and regulatory standards.

QRC Group is hiring a CSV Specialist with bioprocess validation expertise to execute commissioning, qualification and computerized system validation across manufacturing and laboratory environments.

Senior leader needed to build and oversee a world-class global Quality Management System and regulatory compliance program at Melaleuca's Idaho Falls manufacturing operations.

Lead the digital manufacturing strategy and operational technology programs at ElevateBio to modernize MES/LIMS/automation platforms and enable scalable, compliant cell and gene therapy manufacturing.

Dental Insurance

Disability Insurance

Vision Insurance

Equity

Paid Time-Off

Medical Insurance

Mental Health Resources

Paid Holidays

Company Retreats

Hims & Hers seeks a hands-on Quality Control Supervisor to ensure product quality, regulatory compliance, and team coaching at our New Albany non-sterile compounding facility.

Sentec is hiring a Supplier Quality Engineer to oversee supplier qualification, audits, and continuous improvement for electromechanical and injection-molded components in a regulated medical device environment.

Oura is looking for a Medical Device Quality Assurance Engineer to drive compliance, risk management, and verification for SaMD across development and lifecycle activities.

eClinical Solutions is hiring a Senior Clinical Data Manager to lead clinical database design, validation, data cleaning, and sponsor interactions using the elluminate platform.

iRhythm is hiring an experienced RN to lead clinical investigations and post-market safety assessments for its cardiac monitoring products, ensuring patient safety and regulatory compliance.

Experienced quality engineer needed to lead root-cause investigations, SPC rollout, and process-quality improvement across the Milford manufacturing site and global distribution center for Waters Corporation.

OrganOx seeks a CAPA Manager to lead CAPA administration and reporting at its Giralda Farms US site, ensuring regulatory compliance and data-driven continuous improvement.

Lead QMS execution and audit readiness as a Sr. Quality Specialist supporting regulated diagnostics manufacturing at Everlywell.

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 global regulatory strategy and submissions for device and combination products at AbbVie to enable timely approvals and ensure regulatory compliance.

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.

Lead multi-shift powder filling operations at Abbott Nutrition's Casa Grande plant, driving quality, OEE, compliance and team performance.

Celerion seeks an experienced Clinical Data Manager in Tempe, AZ to manage clinical database setup, cleaning, query resolution, and sponsor-facing data management activities across early- to late-phase studies.