21 CFR Part §211 Jobs

The Senior Director of Quality Control leads the Quality Control department at Ratio Therapeutics, a Salt Lake City-based radiopharmaceutical manufacturer dedicated to advancing cancer treatments. This on-site role involves architecting and implementing the analytical and microbiological testing infrastructure for a new facility, including method development, validation, and stability program management. Key responsibilities include overseeing specialized instrumentation, ensuring regulatory compliance with FDA and NRC standards, managing laboratory informatics systems, and leading a growing team of scientists. The position offers the opportunity to shape a state-of-the-art lab culture from the ground up while contributing to the development of novel therapeutic candidates that improve patient lives.

The Senior Quality Engineer role at Belmar Pharma Solutions ensures products and processes comply with USP, FDA, ISO, and cGMP standards within a leading compounding pharmacy. Key responsibilities include reviewing and approving deviations, investigations, CAPAs, and change controls, while also overseeing validation activities and providing leadership to junior quality engineers. The position offers a collaborative environment focused on wellness and accountability, with opportunities for professional growth through coaching and strategic quality system management. The role is based on-site and requires interaction with cross-functional teams to maintain high clinical support and operational excellence.

The Product Analyst II role at Sarah Cannon Research Institute supports digital transformation within a leading oncology research organization. The position serves as a bridge between business stakeholders and IT teams to drive operational excellence and data integrity. Key responsibilities include gathering requirements, building AI-enabled prototypes, translating strategy into user stories, and ensuring compliance with clinical research regulations. This opportunity appeals to mission-driven professionals seeking to advance cancer treatment outcomes through hands-on delivery and rapid experimentation. The role emphasizes continuous learning and the application of emerging digital capabilities in a collaborative, fast-paced environment.

This six-month onsite contract role within the Quality Calibration Lab supports the medical device industry by maintaining inspection, measurement, and test equipment. The technician performs calibration, verification, and adjustment of electrical and mechanical instruments while ensuring compliance with FDA and ISO standards. Key responsibilities include managing field service equipment, documenting results for audit readiness, and coordinating with vendors to reduce calibration backlogs. The position offers the opportunity to work in a regulated environment with a focus on quality assurance and operational efficiency in San Diego.

The Design Quality Engineer I role supports the product development organization at INOVIO, a biotechnology company developing DNA medicines. The position focuses on maintaining compliant design control documentation throughout the product lifecycle to meet QMSR, ISO 14971, and ISO 13485 standards. Key responsibilities include reviewing design plans and verification records, ensuring Design History File completeness, and assisting cross-functional teams with regulatory submissions. This entry-level opportunity offers hands-on experience with medical device compliance frameworks and a collaborative environment where engineers can contribute to life-saving treatments. The role requires a bachelor's degree and 1-2 years of experience in regulated industries, with proficiency in document control systems and risk management tools.

The Senior Medical Device Engineer role at Cresilon involves leading the design, development, and testing of innovative hemostatic medical devices in Brooklyn, New York. Key responsibilities include formulating polymeric materials, defining product requirements, managing design history files, and ensuring compliance with FDA and ISO regulations. The position offers the appeal of working on life-saving technology within a collaborative, hands-on culture that values scientific excellence and rapid innovation. This full-time, on-site position requires a multidisciplinary approach, partnering with cross-functional teams to move projects from concept to launch while mentoring staff and contributing to the company's mission of saving lives.

This Principal Engineer role in Technical Operations focuses on leading process development and continuous improvement within radiopharmaceutical manufacturing. The position involves managing Non-Conformance Reports, Corrective and Preventive Actions, and Change Controls to ensure strict adherence to ISO 13485 and 21 CFR 820 regulations. Key responsibilities include creating Master Batch Records, serving as a Subject Matter Expert for cross-functional teams, and driving data analysis to enhance operational efficiency and product quality. The role offers the opportunity to work on complex, high-impact projects that directly support patient care through innovative technical solutions. It is designed for experienced engineers who thrive in a collaborative environment where they can mentor colleagues and independently solve difficult process challenges.

The Day Habilitation Provider role involves supporting individuals with developmental disabilities and seniors in achieving greater independence through daily living skills and recreational activities. Key responsibilities include assisting with personal care and meal preparation, transporting participants in the community, documenting progress in electronic medical records, and collaborating with care coordinators to implement individualized care plans. The position offers a meaningful opportunity to make a lasting impact on participants' lives within a supportive team environment. The role operates on a standard Monday through Friday schedule and requires reliable transportation and a valid driver's license to facilitate community engagement.

This Market Risk Specialist role within Wells Fargo's Traded Products Counterparty Credit Capital group focuses on managing capital reporting for Counterparty Credit Risk Weighted Assets. Key responsibilities include validating calculated results, analyzing RWA trends and variances, and developing SQL statements to ensure data accuracy. The position also involves coordinating the implementation of emerging capital regulations and partnering with technology teams to enhance strategic reporting solutions. The role appeals to candidates seeking to work with complex derivatives and securities financing transactions in a dynamic environment. It offers a hybrid work arrangement based in Charlotte, North Carolina, and provides opportunities to engage with senior management while contributing to a culture that prioritizes strong risk mitigation and compliance.

The Metals Post Processing Technician role supports the manufacturing of medical devices within a first-shift production team. Key responsibilities include performing secondary processes such as deburring, polishing, and packaging while adhering to strict quality system guidelines and Good Manufacturing Practices. The technician also conducts component inspections, assists with equipment maintenance, and participates in continuous improvement initiatives. This position appeals to mechanically inclined individuals seeking to work with advanced tools like 3D printers and media blasting cabinets in a regulated environment. The role offers a structured schedule with opportunities to contribute to high-precision manufacturing standards.

This full-time Manufacturing Technician role on the 1st shift supports the production and post-processing of medical devices within a regulated environment. The position involves operating various machine shop tools for tasks such as deburring, polishing, and packaging while ensuring strict adherence to Good Manufacturing Practices and FDA quality standards. Key responsibilities include performing equipment set-ups, conducting quality inspections at all manufacturing stages, and participating in continuous improvement initiatives. The role appeals to mechanically inclined individuals seeking a hands-on career in the medical device industry, offering opportunities to work with advanced equipment like 3D printers and contribute to high-quality product development. The work environment is a controlled machine shop setting that requires specific safety protocols and protective gear.

This Post Market Complaint Specialist role within Johnson & Johnson MedTech focuses on reviewing clinical and product complaints to ensure compliance with global medical device regulations. The position involves assessing reportability, coordinating investigations across quality and engineering teams, and managing the operational workflow for individual contributors. Key responsibilities include analyzing complaint data, preparing regulatory submissions, and driving process improvements to identify risks and enhance patient safety. The role offers the opportunity to contribute to life-saving innovations in a collaborative environment that values diversity and professional growth. This is an on-site position based in Danvers, Massachusetts.

The Administrative Manager role supports the Child Research and Study Center at the University at Albany, focusing on the New York State Pyramid Model Implementation project. Key responsibilities include coordinating office procedures, managing personnel records and travel documentation, organizing major events like the annual Pyramid Model Summit, and handling data synthesis and social media updates. This position offers the opportunity to contribute to evidence-based practices that improve student outcomes across New York State. The role is based on campus with occasional travel between locations and provides a collaborative environment within a prestigious R1 research institution dedicated to advancing education and discovery.

The Associate Director, Research Security role at the University of Pennsylvania leads the institution's program for managing federal research data security compliance within a complex academic environment. Key responsibilities include developing risk-based security policies, ensuring adherence to standards such as CMMC and NIST SP 800-171, and coordinating institution-wide initiatives to protect sensitive research data. The position involves auditing system inventories, managing incident response, and serving as a subject matter expert for contract negotiators and research teams. This opportunity appeals to professionals seeking to work at a world-renowned Ivy League university with a collaborative culture, offering access to extensive professional development, comprehensive benefits, and a dynamic urban campus in Philadelphia.

This Quality Assurance Engineer role supports the manufacturing and maintenance of turbine engine components within a dedicated engineering team. The position involves interpreting engineering drawings, developing quality procedures, and leading problem-solving initiatives using 8D methodologies and statistical analysis. Key responsibilities include managing configuration documents, driving cost reduction and yield improvement goals, and providing technical support to internal and external stakeholders. The role appeals to candidates seeking to apply Six Sigma and ISO certification knowledge in a technical environment. It requires a bachelor's degree in engineering and offers opportunities to work with advanced quality systems while contributing to critical aerospace standards.

The Director, Pre Award and Sponsored Award Programs role leads centralized research administration functions at Tufts Medical Center, reporting to the VP of Research Administration. Key responsibilities include serving as the Institutional Signature Authority for grants and contracts, negotiating complex agreements with federal and industry partners, and developing policies to ensure compliance with federal regulations. The position also involves supervising staff, streamlining contract execution processes, and providing training to faculty and research administrators. This opportunity appeals to candidates seeking to drive innovation within a world-renowned academic medical center, offering a chance to impact life-saving research while working in a collaborative environment dedicated to advancing healthcare.

This entry-level ABA Therapist role involves providing one-on-one behavioral interventions to children with Autism in home or community settings. The position is ideal for psychology students or those with childcare experience, offering comprehensive free training to become a Registered Behavior Technician. Key responsibilities include implementing care plans, recording session data, and collaborating with families to foster positive development. The role appeals to candidates seeking flexible part-time hours that accommodate school schedules, with a focus on job security and career growth within the ABA industry. A six-month commitment is required, and the schedule typically runs weekday afternoons with weekend availability.

This remote Cardiac Rhythm Management Technical Field Engineer role supports Medtronic's mission to advance healthcare through innovation in Indianapolis and surrounding regions. The position requires residing within the territory and driving to multiple accounts to serve as a technical and clinical expert. Key responsibilities include leading regional education and training activities for internal teams and external customers, providing expert guidance on implant procedures and product therapies, and collaborating with sales leadership to execute strategic business goals. The role appeals to professionals seeking a career defined by purpose, offering opportunities to mentor colleagues, influence product development through direct feedback, and work within a collaborative culture that values continuous learning and mission-driven impact.

The Operating Unit Legal Lead Counsel role provides strategic legal support to the Neuromodulation business unit at Medtronic. The position involves advising leadership on commercial strategy, negotiating complex contracts, and managing cross-functional risks in areas such as healthcare compliance, intellectual property, and mergers. Key responsibilities include serving as a trusted advisor to business stakeholders, leading legal training initiatives, and guiding business development projects. This opportunity appeals to experienced attorneys seeking to advance a mission of alleviating pain and restoring health within a collaborative engineering culture. The role is based onsite in Minneapolis, requiring a minimum of four days per week to foster professional growth and cross-functional teamwork.

This travel nursing position places a Registered Nurse in a Float capacity within the Critical Care Unit at a facility in Augusta, Georgia. The role involves working 36-hour weeks on 12-hour night shifts for a 12-week duration, requiring adaptability across various critical care environments. Key responsibilities include delivering high-quality patient care, managing complex medical equipment, and collaborating with diverse medical teams to ensure optimal outcomes. The opportunity is appealing due to the company's commitment to compassionate, faith-based values and the provision of comprehensive benefits including housing options, medical coverage, and continuing education. This arrangement offers healthcare professionals the chance to gain diverse clinical experience while working with a supportive organization dedicated to meaningful relationships.

This travel nursing role places a Registered Nurse in the Medical-Surgical Telemetry department at a facility in Augusta, Georgia. The position involves working 36-hour weeks on 12-hour night shifts for a 14-week duration. Key responsibilities include delivering comprehensive patient care, monitoring telemetry data, and collaborating with the medical team to ensure patient safety and recovery. The opportunity is appealing due to the company's focus on compassionate, faith-based values and authentic relationships with healthcare professionals. The arrangement offers guaranteed hours, continuing education support, and access to company-provided housing options, allowing nurses to gain diverse clinical experience while maintaining work-life balance.

This 13-week travel nursing position places a Registered Nurse in the Progressive Care Unit at a facility in Columbus, Ohio. The role involves working 36-hour weeks on 12-hour night shifts, providing critical care to patients in a specialized unit. Key responsibilities include monitoring patient vitals, administering treatments, and collaborating with the medical team to ensure high-quality care standards. The position is appealing due to the opportunity to work with a compassionate, faith-based organization that prioritizes meaningful relationships and community service. Benefits include guaranteed hours, continuing education support, and comprehensive health coverage. The assignment offers a structured travel experience with company-provided housing options available.

This role involves operating shuttle buses and smaller passenger vehicles to provide transit services for the University of Utah campus community. Key responsibilities include transporting passengers along fixed routes, including ADA-compliant service, securing wheelchair passengers, conducting daily vehicle safety inspections, and maintaining vehicle cleanliness. The position offers paid CDL training and testing for entry-level candidates, making it an accessible opportunity for those with little prior experience. The role appeals to individuals seeking stable employment within a supportive university environment, emphasizing safety, punctuality, and professional customer service.

This full-time Physical Therapist role at Rebecca School supports students aged 3 to 21 with neurodevelopmental delays using the DIRFloortime model. The position involves conducting evaluations, developing individualized treatment plans, and providing direct therapy to improve motor coordination, balance, and physical independence. Key responsibilities include collaborating with a multidisciplinary team to integrate motor goals into daily classroom activities and educating staff and families on safety strategies. The role is appealing due to its student-centered mission, comprehensive benefits including tuition reimbursement and a 401(k) match, and a supportive culture that prioritizes wellness and professional growth.

This full-time Senior Manufacturing/Production Operator role is based on the 3rd shift at a defense contractor facility in Scottsdale, Arizona. The position involves performing complex assembly, wiring, hand soldering, and cable harnessing on electronic and mechanical subassemblies while interpreting schematics and conducting electrical tests. Key responsibilities include integrating sub-assemblies into final hardware, performing system refurbishment, and utilizing surface mount equipment. The role appeals to candidates seeking to work with top-secret technologies and a team of bold thinkers committed to innovation. It offers opportunities for professional growth and continuous learning within a collaborative environment. U.S. citizenship and a valid security clearance are required for this on-site position.