Fda 21 CFR 820 Jobs

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 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 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 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 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 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 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 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 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 Biostatistician II role supports clinical research programs by independently leading studies and delivering high-quality statistical analyses. Key responsibilities include developing Statistical Analysis Plans, generating randomization schedules, and creating tables, figures, and listings using SAS. The position requires reviewing protocols, validating programming outputs, and ensuring compliance with regulatory guidelines such as FDA and ICH standards. This opportunity is appealing for professionals seeking to work on Phase 1 trials and early safety endpoints within a collaborative, client-focused environment. The role involves cross-functional teamwork and offers the chance to mentor junior staff while maintaining flexibility in work assignments.

The Manager of Research Blood Cancer role provides leadership for the research program at Sarah Cannon Research Institute, a leading oncology organization dedicated to advancing cancer treatments. The position involves overseeing clinical trial operations, ensuring compliance with FDA and GCP guidelines, and managing fiscal responsibilities including budget monitoring and billing outcomes. Key duties include directing staff recruitment and development, optimizing electronic medical record processes, and analyzing data to improve trial execution and patient care. This position appeals to mission-driven professionals seeking to make a tangible impact on cancer outcomes within a collaborative, community-based environment. The role offers opportunities for professional growth through continuing education and participation in high-impact drug development initiatives.

The Mix Coat Manufacturing Operator II role at LTS Lohmann is a skilled position within the manufacturing team responsible for producing oral and transdermal drug delivery systems. Based in West St. Paul, Minnesota, this second-shift position involves executing equipment setup, operating mixing and coating machinery, and performing in-process quality sampling. Key responsibilities include adhering to strict GMP, FDA, and DEA compliance standards, maintaining accurate production documentation, and supporting continuous process improvements. The role appeals to candidates seeking professional growth within a collaborative environment where they can directly contribute to improving patient outcomes. The position offers a supportive culture focused on teamwork and accountability, with opportunities for development in a global pharmaceutical partner organization.

The Senior Study Startup Specialist role leads complex global clinical trial start-up activities for SystImmune, a well-funded biopharmaceutical company focused on innovative cancer treatments. The position serves as a subject matter expert in site activation, regulatory submissions, and process optimization while mentoring junior team members. Key responsibilities include developing site activation strategies, managing contract and budget negotiations, overseeing CRO deliverables, and ensuring compliance with global regulations like ICH-GCP. This opportunity appeals to professionals seeking to drive continuous improvement in a fast-paced environment with a mission to advance oncology therapies. The role offers a hybrid work arrangement requiring three days onsite at the Princeton, NJ location.

The Deviation Investigation Supervisor role is based in Portsmouth, NH, and involves leading a team of investigators within the Quality Systems department. Key responsibilities include managing team workload, providing technical guidance on complex investigations, and ensuring strict adherence to cGMP standards and regulatory expectations. The position requires cross-functional collaboration with Manufacturing and Quality teams to drive continuous improvement and reduce deviations. This opportunity is appealing for its focus on professional development through mentorship and career planning, as well as the chance to contribute to a global mission of manufacturing life-saving medicines. The role operates on a standard Monday through Friday schedule within a collaborative culture that values accountability and innovation.

The Clinical Research Coordinator role at Huntsman Cancer Institute supports the Principal Investigator in managing the implementation and quality control of cancer research studies across the Intermountain West region. Key responsibilities include ensuring regulatory compliance with FDA and IRB guidelines, managing study budgets and participant enrollment, and coordinating all aspects of patient interactions from screening to informed consent. The position also involves supervising junior staff and maintaining detailed research documentation. This opportunity appeals to professionals seeking to contribute to a mission-driven organization dedicated to reducing the global cancer burden. The role offers a collaborative environment with opportunities for professional growth, requiring a blend of administrative precision and patient-centered care within a hybrid work setting.

The Quality Design Assurance Engineer I or II role serves as a core project team member within Heraeus Medevio, supporting the design and development of complex medical devices such as catheters and guidewires. Key responsibilities include collaborating across functional areas to drive project deliverables, developing quality and risk management plans, reviewing nonconforming products, and ensuring compliance with FDA and ISO regulations. The position offers an opportunity to work in a culture that values curiosity, continuous learning, and growth within a global organization dedicated to improving lives. This is an onsite position based in Fridley, Minnesota, with occasional travel required to the White Bear Lake location.

This full-time Engineering Technician role supports injection molding operations within PMC SMART Solutions, a contract manufacturer producing life-saving medical devices and automotive components. The position involves executing mold trials, validating processes, and troubleshooting automation systems to ensure production efficiency. Key responsibilities include assisting with tooling setups, monitoring product quality, and collaborating with cross-functional engineering teams to drive continuous improvement initiatives. The role appeals to candidates seeking hands-on technical work in a regulated, high-impact environment where their contributions directly support critical healthcare and safety products. The position offers a collaborative culture focused on operational excellence and offers opportunities for professional growth within a certified, award-winning organization.

The Manufacturing Specialist role serves as a primary process owner and subject matter expert within Evonik's Birmingham Labs, supporting PDS Services and Medical Devices. Key responsibilities include executing cGMP batch manufacturing in cleanroom environments, ensuring regulatory compliance with FDA and EMA standards, and leading training programs for frontline staff. The position also involves managing SOPs, driving continuous improvement, and supporting validation activities. This opportunity appeals to candidates seeking to shape sustainable solutions within a collaborative culture that offers hybrid working flexibility and robust career development. The role is based on-site with shift flexibility required.

The Clinical Trial Monitor II role within the Clinical Trials Office at Dana-Farber Cancer Institute ensures research compliance with federal regulations and institutional policies. Key responsibilities include conducting remote data reviews and onsite monitoring visits to verify data accuracy, developing monitoring plans, and mentoring new team members. The position requires managing multiple projects simultaneously while promoting a culture of regulatory awareness. This opportunity appeals to professionals seeking to contribute to groundbreaking cancer research within an inclusive, mission-driven academic environment. The role is based in Boston with occasional travel required for onsite visits.

The Training Specialist role within the Quality and Compliance department supports the SOFIE network by developing and facilitating educational programs for manufacturing and operational staff. Key responsibilities include assessing training needs, creating individualized and group curricula, delivering face-to-face and virtual workshops, and ensuring compliance with cGMP regulations through collaboration with Quality Assurance and Sterility Assurance teams. The position requires domestic travel to various facilities to conduct hands-on training and manage onboarding processes. This opportunity appeals to candidates seeking a dynamic environment where they can drive organizational growth, implement innovative learning strategies, and contribute to high-quality pharmaceutical production standards.

The Manufacturing Engineer II role supports the medical device team in optimizing clean room processes for products transitioning from new product introduction to commercial manufacturing. Key responsibilities include designing process improvements, managing manufacturing launches, and developing engineering documentation while ensuring compliance with FDA and ISO regulations. The position involves collaborating with cross-functional teams to solve root cause issues and implement robust production methods. This opportunity appeals to candidates seeking a dynamic environment with a focus on quality and efficiency, offering a collaborative culture and comprehensive benefits including flexible time off and paid parental leave.

This Management Consulting Associate role within RSM's Life Sciences practice supports middle market organizations in solving complex operational and business challenges. Key responsibilities include analyzing data to define current-state operations, developing recommendations for quality and regulatory improvements, and creating client deliverables such as process maps and presentations. The position offers a collaborative environment with exposure to diverse engagements across the Life Sciences value chain, fostering professional growth alongside experienced leaders. The role appeals to candidates seeking a culture that empowers personal and professional development while offering schedule flexibility to balance work and life. Travel is required approximately 25% of the time to support client engagements.