Fda 21 CFR 820 Jobs

This full-time second-shift warehouse associate role at Kenco Logistics involves picking, packing, and preparing orders for shipment within a supportive 3PL environment. Key responsibilities include measuring and weighing products, operating equipment like forklifts, affixing shipping labels, and conducting quality inspections to ensure accuracy and safety compliance. The position appeals to candidates seeking a career in the supply chain industry with a focus on continuous improvement and operational excellence. The role offers a collaborative culture that values employee growth, comprehensive benefits including health insurance and paid time off, and a stable work arrangement with no travel requirements.

This Project Engineer role at Globus Medical focuses on developing innovative surgical instruments and implants to improve patient outcomes for musculoskeletal disorders. The position involves designing products using Creo and SolidWorks, managing project plans and FDA Design History Files, and gathering market feedback from surgeons to define specifications. Key responsibilities include overseeing design verification, coordinating with prototype shops and vendors, and supporting product launches through sales training. The role appeals to candidates seeking to contribute to a mission-driven culture that values innovation, teamwork, and rapid response to customer needs. The position requires a blend of mechanical design expertise and regulatory knowledge within a deadline-driven environment.

This Senior Manager role within the Oncology Clinical Development team provides scientific oversight for clinical trials supporting the company's cancer treatment portfolio. Key responsibilities include ensuring data integrity and quality, authoring critical regulatory documents such as protocols and informed consent forms, and leading data review strategies to analyze emerging safety profiles. The position involves collaborating with cross-functional partners to drive study execution and presenting findings to governance bodies. The role is appealing for its opportunity to contribute directly to patient care through impactful oncology research, offering a collaborative environment that values innovation and global perspectives. This hybrid position requires on-site presence approximately 2.5 days per week.

This full-time Industrial Sewing Operator role, located in Chanhassen, Minnesota, involves operating industrial sewing machines to assemble medical device components from materials like lamb's wool pelts. Key responsibilities include following strict production specifications, inspecting finished products for quality and consistency, and maintaining accurate FDA and ISO-regulated documentation. The position offers a path to permanent employment with a supportive team culture that includes monthly on-site meals. The role requires prior sewing experience and strong manual dexterity, operating on a standard weekday schedule from 7:00 am to 3:00 pm.

This full-time Clinical Research Coordinator role supports the Division of Urology within the Department of Surgery, managing operations for both adult and pediatric research programs. Key responsibilities include overseeing research procedures, ensuring regulatory compliance, managing data acquisition and entry, and coordinating patient screening and follow-up. The position also involves assisting with IRB protocol development and participating in grant submissions. The role appeals to organized professionals seeking to contribute to impactful medical research in a collaborative environment. It requires strong communication skills and the ability to work independently within an office setting.

The Technical Document Coordinator role is based at the Abbott Nutrition facility in Sturgis, Michigan, supporting safe and compliant contractor operations within the healthcare division. Key responsibilities include creating and maintaining risk assessments for construction and maintenance activities, ensuring all work meets FDA, OSHA, and internal quality standards, and serving as a liaison between external contractors and internal engineering and operations teams. This position appeals to candidates seeking a stable career with a global leader recognized for its commitment to employee well-being and community impact. The role offers robust professional development opportunities, including tuition assistance and onboarding programs, within a clean and supportive work environment. The position is on-site with no travel required and focuses on fostering a strong safety culture while contributing to the production of essential nutrition products.

The Product Development Engineer role at Glenroy, Inc. supports sales, operations, and supply chain teams by providing technical expertise for new raw materials and packaging applications. Key responsibilities include designing film and lamination structures that balance performance with cost, managing Bills of Materials in the ERP system, and leading cross-functional projects through the development lifecycle. The engineer also conducts material testing, documents trial results, and provides direct technical support to customers. This position offers the appeal of working for a family-owned manufacturer recognized for safety and a supportive culture that values growth and innovation. The role is based on-site in Menomonee Falls, Wisconsin, within a clean, climate-controlled facility, and includes opportunities to contribute to sustainability initiatives and access comprehensive professional development resources.

The Material Handler role on the second shift supports the Preweigh, Compounding, and Production teams at kdc/one Columbus. Key responsibilities include operating processing and powered industrial equipment, sanitizing tools and stainless steel totes, transferring batches between tanks, and managing hazardous waste in compliance with FDA good manufacturing practices. The position appeals to candidates seeking a stable full-time opportunity within a company that creates formulations for top beauty and personal care brands. The role requires a high school diploma or equivalent and values prior experience in compounding or sanitation. The work is performed on-site in New Albany with potential for overtime based on production schedules.

This full-time Medical Professional role at Octapharma Plasma involves evaluating donor eligibility, managing plasma collection procedures, and ensuring strict regulatory compliance within a donor center. Key responsibilities include conducting medical history reviews, monitoring donor health during plasmapheresis, and providing immediate care for any adverse reactions. The position appeals to licensed healthcare providers such as paramedics or LPNs by offering a dynamic environment where no two days are the same, allowing professionals to make a direct, life-saving impact on patients worldwide. The role supports a collaborative culture focused on compassion and expertise, with opportunities for growth, mentorship, and flexible scheduling across various shifts.

This entry-level manufacturing role operates within the Powder Packaging department at Abbott's Sturgis, Michigan facility, supporting the production of essential nutrition products. The position focuses on the secondary packaging process, where the incumbent operates equipment such as depalletizers and labelers, conducts quality inspections, and manages batch documentation. Key duties include performing preventative maintenance, executing sanitation procedures, and operating forklifts while adhering to strict FDA and OSHA compliance standards. The role is appealing due to Abbott's reputation as a global healthcare leader offering extensive career development, tuition reimbursement, and a supportive culture recognized for diversity and work-life balance. This is a third-shift position requiring no travel, providing an opportunity to contribute to life-changing products while growing within a stable, family-oriented organization.

This full-time Clinical Trials Assistant role supports the Shockwave Reducer project within Johnson & Johnson's R&D Operations team in New Brighton, Minnesota. The position involves managing study payments and invoice processing, coordinating the shipment of clinical study supplies, and maintaining the Trial Master File to ensure regulatory compliance. Key responsibilities also include handling project communications, updating clinical databases, and assisting with meeting logistics. The role offers the opportunity to contribute to innovative cardiovascular treatments while working in a fast-paced, inclusive environment that values professional growth and collaboration.

This full-time Technical Analyst role supports the JD Edwards EnterpriseOne environment within Trelleborg Medical Solutions. The position involves developing and customizing system objects like UBEs and business functions, translating functional requirements into technical solutions, and integrating JDE with external systems via APIs and Orchestrators. Key responsibilities include troubleshooting production issues, managing version upgrades, performing data conversions, and leading testing phases throughout the software development lifecycle. The role offers the opportunity to impact the production of life-saving devices within a global organization that promotes internal growth. While primarily remote or office-based, the position requires up to 10% travel to domestic and international sites. The environment is clean and climate-controlled, fostering a collaborative culture focused on process efficiency and automation.

The Manufacturing Process Engineer role at MMQCI focuses on optimizing biomanufacturing processes to ensure efficiency, quality, and regulatory compliance within a growing diagnostic company. Key responsibilities include evaluating and automating production systems, supporting new product scale-up and equipment validation, and driving continuous improvement initiatives using LEAN and Six Sigma methodologies. The position requires troubleshooting operational issues, maintaining cGMP and FDA compliance, and collaborating with cross-functional teams to enhance manufacturing reliability. This opportunity is appealing for its mission-driven culture, the chance to make a meaningful impact on patient care through quality control innovation, and its location in a state-of-the-art facility in southern coastal Maine surrounded by outdoor recreational activities.

This fully remote role involves serving as a Bilingual Health Educator for a patient support line, requiring fluency in both English and Spanish. The position focuses on answering calls during evenings and weekends, providing educational support to patients and caregivers while adhering to strict privacy regulations like HIPAA. Key responsibilities include following established scripts, maintaining disease-specific knowledge, and collaborating with internal teams to address patient needs. The role appeals to those seeking a mission-driven environment centered on compassionate care and professional growth within the pharmaceutical industry. It offers the flexibility of working from home while contributing to a supportive, inclusive team culture.

The Pharmacy Manager role at Amazon Pharmacy involves leading a small-format site to ensure safe, compliant, and efficient medication delivery. Key responsibilities include overseeing daily operations, managing a team of pharmacists and technicians, verifying prescriptions, and driving process improvements to meet customer service goals. The position requires maintaining strict adherence to federal and state regulations while fostering a culture of patient safety and continuous learning. This opportunity appeals to those seeking a dynamic environment where innovation meets healthcare, offering a chance to shape the future of online pharmacy. The role is based in Wixom, Michigan, with a flexible schedule that may include weekends and holidays, and supports long-term career growth across multiple facilities.

This full-time Blood Bank Medical Director role within the Department of Pathology and Laboratory Medicine at Tufts Medical Center provides medical leadership for transfusion services, including the blood bank, apheresis unit, and stem cell laboratory. Key responsibilities involve overseeing blood product utilization, ensuring regulatory compliance, providing clinical consultations for complex patient cases, and supporting research initiatives. The position offers an academic appointment at Tufts University School of Medicine with opportunities to teach residents and medical students. The role is appealing due to its integration with a high-volume Level 1 trauma center, robust transplant programs, and a collaborative environment that values advancing knowledge through clinical and translational research. The position is based in downtown Boston.

This Principal Mechanical Engineer role serves as a technical lead within TransMedics' sustaining engineering team, driving innovation across the company's on-market product portfolio. Key responsibilities include leading end-to-end mechanical design development, conducting advanced structural and thermal analyses, and chairing program-level design reviews. The position also involves defining test methodologies, managing engineering change orders, and collaborating with manufacturing partners to ensure design for manufacturability. The role appeals to candidates seeking to impact patient lives by expanding access to viable donor organs in a mission-driven environment. While the position is based in the Boston area with potential relocation to Somerville by 2028, it offers opportunities for professional growth, cross-functional collaboration, and the chance to shape engineering standards in a high-impact medical technology setting.

This full-time onsite role at a Fortune 500 company involves supporting product development engineering within a regulated manufacturing environment. The position focuses on generating and executing formal test protocols, operating laboratory equipment, and maintaining precise technical documentation. Key responsibilities include tracking development builds, assisting with root cause investigations, and ensuring compliance with FDA and ISO standards. The role offers potential for permanent employment based on performance and provides opportunities for career growth within a collaborative team. Candidates will work in a lab and office setting in Salt Lake City, Utah, contributing to high-quality medical device development.

This Lead Clinical Research Coordinator role at ProPharma involves managing and coordinating daily activities for Phase II-III industry-sponsored clinical trials from initiation to close-out. The position requires ensuring protocol compliance, data integrity, and participant safety while handling vendor management, subject recruitment, adverse event reporting, and regulatory documentation. Key responsibilities include performing clinical procedures like phlebotomy, leading monitoring visits, and collaborating with investigators and sponsors to optimize study operations. The role is appealing for its opportunity to work with a diverse team in a culture that values innovation, diversity, and authentic collaboration. While the position requires residency in New York City, it offers a hybrid work arrangement that balances remote flexibility with in-person office collaboration.

This senior leadership role at Neurocrine Biosciences provides strategic direction for clinical database programming across the company's neuroscience drug development portfolio. The position involves defining industry standards, overseeing database quality and regulatory compliance, and mentoring team members while managing complex technical projects. Key responsibilities include leading database builds and validation, evaluating new technologies, and ensuring inspection readiness for global submissions. The role appeals to experts seeking to drive innovation in a mission-driven culture focused on relieving patient suffering. It offers the opportunity to influence cross-functional decisions and shape long-term data strategies within a collaborative environment.

This full-time Warehouse Associate role at Kenco Logistics involves picking, packing, and preparing orders for shipment within a dynamic third-party logistics environment. Key responsibilities include measuring and weighing products, operating equipment such as forklifts, affixing shipping labels in compliance with regulations, and conducting quality inspections to ensure accuracy. The position offers a supportive culture that prioritizes employee growth, safety, and continuous improvement, allowing individuals to make a tangible impact in the supply chain industry. The role is based on-site with no travel required and provides opportunities for career development within a company that values integrity and innovation.

The Senior Director, Global Product Strategy & Product Management role serves as a senior leader within Accuray's Clinical Innovation and Education department, responsible for defining the multi-year strategy and direction of the company's cancer treatment portfolio. Key duties include developing long-term product roadmaps, overseeing the full product lifecycle from concept to launch, and integrating customer feedback with market intelligence to drive innovation. This position requires close collaboration with R&D, commercial teams, and executive leadership to ensure products meet clinical needs and business goals. The role is appealing for its opportunity to make a direct impact on cancer patient outcomes while leading a global team in a culture that values clinical curiosity, operational excellence, and patient-first innovation.