21 CFR Part 210 Jobs

This onsite Quality Engineer role at Solventum in Columbia, Missouri, supports the healthcare division by ensuring product safety and regulatory compliance. The position involves providing engineering support for commercialized products, managing change and risk controls, and leading investigations into nonconforming materials or supplier issues. Key responsibilities include participating in ISO and FDA audits, utilizing Lean Six Sigma methodologies for continuous improvement, and collaborating with manufacturing teams to resolve quality challenges. The role appeals to candidates seeking to contribute to a mission-driven company focused on improving lives through innovative healthcare solutions. It offers a collaborative environment with opportunities for professional growth and may include up to 5% domestic travel.

The Director, Quality Engineering role leads the quality function within BD's global medical technology division, ensuring devices meet rigorous safety and regulatory standards. Key responsibilities include developing strategic quality plans aligned with FDA and ISO requirements, managing and mentoring engineering teams, and overseeing design controls, risk management, and continuous improvement initiatives across the product lifecycle. The position appeals to leaders seeking to drive innovation in healthcare while fostering a collaborative culture that values learning and growth. The role is based in San Diego with a requirement for four days of on-site presence per week to support cross-functional teamwork 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.

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 Clinical Trials & Data Management team within the Department of Biostatistics is seeking Research Assistants, Associates, and Specialists to support mission-critical research applications. The role involves developing data management plans, designing data collection forms and database systems, and performing data cleaning, reconciliation, and reporting. Candidates will collaborate with external partners and internal IT teams to ensure data verification and validation. This position offers remote or hybrid work flexibility within Iowa, a collaborative environment focused on public health, and opportunities for professional growth through the use of advanced statistical and database tools.

The Software Compliance Engineer role supports the Software Quality Assurance team within Abbott's Diabetes Care division in Alameda, California. This position ensures that medical device software and firmware meet strict regulatory standards, including FDA QSR and ISO guidelines. Key responsibilities include reviewing change plans and test reports to verify compliance, managing defect tracking processes, and serving as a subject matter expert during internal and external audits. The role involves active participation in Agile development cycles and collaboration with cross-functional engineering teams. This opportunity appeals to candidates seeking to contribute to life-changing healthcare technologies while working in a globally recognized company that values diversity and professional growth. The position requires occasional travel and is based at the Alameda facility.

The DeltaV Batch Automation Engineer role is based onsite in Indianapolis and focuses on process automation within biotechnology and life sciences manufacturing. The position involves designing, implementing, and supporting Emerson DeltaV DCS and Batch systems while applying ISA-88 batch control principles to skid-based process systems. Key responsibilities include troubleshooting live systems in regulated environments, collaborating with validation teams to ensure cGMP compliance, and managing capital projects such as system upgrades and migrations. This opportunity appeals to engineers seeking hands-on technical work with system ownership in a collaborative environment. The role offers long-term project stability and the chance to contribute to critical manufacturing operations that support safe and compliant production.

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.

This Data Engineer role blends traditional database administration with modern data engineering to support enterprise analytics and system integration. The position involves designing and maintaining scalable ETL pipelines using Azure Data Factory, managing the lifecycle of on-prem and cloud databases, and optimizing performance for SQL Server and Oracle environments. Key responsibilities include developing data models for Power BI, implementing data governance frameworks, and ensuring compliance with security standards like NIST and ISO 27001. The role appeals to professionals seeking to work in a regulated environment where they can influence data strategy while collaborating with cross-functional teams. The position requires hybrid work arrangements with occasional travel to company sites and the ability to perform physical tasks such as lifting and climbing stairs.

The Manager, Warehouse Operations leads multiple facilities within Fujifilm Healthcare Americas, overseeing shipping, receiving, returns, and inventory accuracy while ensuring regulatory compliance. Key responsibilities include mentoring supervisors, enforcing safety protocols, managing labor allocation, and implementing lean methodologies to drive continuous improvement. The role requires close collaboration with transportation and logistics teams to ensure seamless supply chain execution. This position is appealing for its opportunity to support a global mission of innovation in healthcare and non-destructive testing, offering a dynamic environment that values creativity and professional growth. Based in Lexington, Massachusetts, the role involves occasional travel and operates within a flexible, collaborative culture.

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.

This part-time school bus driver role in Rochester, MN focuses on safely transporting students to and from school and extracurricular activities. Key responsibilities include conducting pre-trip vehicle inspections, supervising student boarding and unloading, maintaining order on the bus, and communicating with school staff regarding student needs. The position is appealing for its flexible split-shift schedule that avoids nights, weekends, and holidays, along with comprehensive training for those without prior commercial driving experience. The role offers opportunities for career advancement within a large organization, a supportive community impact, and benefits including health insurance and retirement plans.

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 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.

The Property Maintenance Technician I role supports the Facilities team at Fairbanks Resource Agency in maintaining residential properties to high standards. Key responsibilities include responding to work orders for general repairs in plumbing, electrical, HVAC, and carpentry, as well as performing groundskeeping, custodial duties, and apartment refurbishment during vacancies. The position requires handling emergency calls, ensuring safety compliance, and assisting with regulatory inspections. This role appeals to candidates seeking a hands-on position with opportunities for professional growth through training and the chance to make a direct impact on community living environments. The job involves a mix of indoor and outdoor work, requires reliable transportation, and includes an on-call rotation schedule.

The Regulatory Associate role supports oncology clinical trials at UNC LCCC by ensuring strict adherence to federal regulations and Good Clinical Practice. Key responsibilities include preparing and submitting regulatory applications to the IRB and various committees, drafting informed consent forms, and managing compliance tracking for assigned disease groups. The position also involves preparing for audits, maintaining electronic regulatory binders, and contributing to process improvements through standard operating procedures and team mentoring. This opportunity appeals to candidates seeking to advance their expertise in clinical research compliance within a mission-driven environment focused on patient safety and research integrity. The role requires occasional evening or weekend availability and offers a collaborative setting for professional growth in a specialized oncology research department.

This senior individual contributor role serves as the principal technical authority for mechanical and electro-mechanical engineering at Henry Schein's Lompoc, California manufacturing site. The position focuses on leading complex problem-solving investigations, driving operational efficiency through Lean and Six Sigma methodologies, and maintaining technical files for medical device compliance. Key responsibilities include providing hands-on engineering support for production issues, designing automation and maintenance strategies, and mentoring junior engineers without direct people-management duties. The role appeals to experts seeking to influence technical direction in a highly regulated environment while contributing to the expansion of global manufacturing capabilities. This is a full-time, on-site position requiring daily presence on the production floor.

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.

The Patient Specific Design Engineer role at restor3d focuses on creating custom 3D printed orthopedic implants and surgical instruments to enhance patient reconstruction. Key responsibilities include analyzing CT scan data to generate 3D models, designing patient-specific implants and surgical guides, and collaborating with operations to ensure designs are optimized for various 3D printing technologies. The position also involves attending orthopedic cases to support the surgical process and maintaining quality documentation for regulated medical devices. This opportunity appeals to engineers seeking to apply their skills in a mission-driven environment that directly impacts patient care. The role offers the chance to work with cutting-edge biomedical materials and provides flexibility for independent ownership of cases within a collaborative team setting.

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.