Fda 21 CFR Part 820 Jobs

The Associate Director, Global Quality Operations role leads initiatives to drive operational excellence and optimize quality system processes within a global pharmaceutical organization. Key responsibilities include developing proactive risk management frameworks aligned with ICH Q9 principles, overseeing the design and standardization of global quality systems such as deviation management and CAPA, and ensuring compliance with international regulatory requirements like FDA and EMA standards. The position offers the appeal of leading digital transformation efforts in a collaborative, matrixed environment while fostering a culture of continuous improvement and patient-centricity. This strategic leadership role supports cross-functional alignment across Supply Chain and Regulatory Affairs to enhance efficiency and accountability worldwide.

The Associate Director, Global Quality Operations leads initiatives to drive operational excellence and optimize quality system processes within a global pharmaceutical organization. Key responsibilities include developing proactive risk management frameworks aligned with ICH Q9 principles, overseeing the design and standardization of global quality systems such as deviation management and CAPA, and ensuring compliance with international regulatory requirements like FDA and EMA standards. The role involves leading cross-functional collaboration to streamline workflows and supporting digital transformation efforts. This position offers the opportunity to work in a matrixed global environment where strategic thinking and process improvement methodologies directly impact patient safety and business goals. The role emphasizes a culture of respectful collaboration, empowered professional development, and impactful communication across diverse teams.

This full-time Clinical Account Representative role within Abbott's Heart Failure division focuses on driving the adoption and utilization of CardioMEMS technology across the Houston region. The position combines sales execution with clinical expertise to support key accounts, optimize patient monitoring workflows, and deliver technical education to physicians and healthcare administrators. Key responsibilities include managing high-volume accounts, achieving utilization targets, conducting product demonstrations, and providing troubleshooting support for remote monitoring systems. The role offers the appeal of working for a globally recognized healthcare leader with a strong commitment to diversity and employee development. It features a remote work arrangement with approximately 25% travel, providing flexibility while maintaining a collaborative connection with the broader sales and clinical teams.

The Associate Director of Treasury role at BridgeBio leads global treasury operations for a biopharmaceutical company focused on developing life-changing medicines for rare diseases. Reporting to the Chief Accounting Officer, the position provides strategic oversight of cash liquidity, financial risk management, and banking relationships across commercial, R&D, and manufacturing functions. Key responsibilities include managing rolling cash flow forecasts for clinical trials and milestone payments, executing hedging strategies for foreign exchange and interest rate exposure, and optimizing the global bank account structure. The role appeals to candidates who value a mission-driven culture that encourages experimentation and the ethical use of AI to drive efficiency. It offers a hybrid work arrangement, opportunities to mentor a high-performing team, and a collaborative environment where professionals can influence executive strategy while supporting the rapid advancement of the pharmaceutical pipeline.

This full-time Biomedical Equipment Technician Specialist role supports U.S. government healthcare operations by installing, maintaining, and repairing clinical equipment across hospitals and field environments. Key responsibilities include performing preventive maintenance and electrical safety testing, diagnosing equipment malfunctions, and managing lifecycle planning while ensuring compliance with federal safety standards. The position offers the opportunity to serve a vital mission within a military-friendly organization that values compassion and technical excellence. The role involves a mix of on-site work in clinical settings and maintenance shops, with occasional local travel and on-call availability to support operational readiness.

This part-time Dining Server role at Cedarhurst Senior Living supports the delivery of exceptional dining experiences for residents and guests within a senior care community. Key responsibilities include taking and serving food orders, maintaining strict food safety and sanitation standards, assisting with special events and catering, and ensuring dining areas remain welcoming and clean. The position offers morning and evening shifts with a rotating weekend schedule. The role is appealing due to the organization's commitment to employee growth through comprehensive training and internal promotion opportunities, a supportive culture centered on empathy and respect, and a unique rewards system that recognizes dedication. The position fosters meaningful daily interactions while contributing to the wellbeing of the senior community.

This full-time Lead Software Engineer role is based in Newark, Delaware, within Hologic's medical device division, focusing on breast and skeletal health solutions. The position involves leading the design, development, and documentation of safety-critical software for clinical and internal users using C#, WPF, and .NET. Key responsibilities include writing and testing regulated code, mentoring junior engineers, driving Agile process improvements, and collaborating with cross-functional teams to ensure regulatory compliance. The role appeals to candidates seeking to build life-changing products while fostering a high-performing team culture. Hologic supports professional growth through comprehensive training and development opportunities. The work arrangement is hybrid, combining on-site collaboration with remote flexibility.

This Principal Data Science Engineer role focuses on developing AI and machine learning algorithms to enhance organ preservation technology and improve patient outcomes in the healthcare sector. The position involves managing the end-to-end lifecycle of data-driven software products, designing clinical decision support models, and ensuring strict adherence to regulatory standards like HIPAA and GDPR. Key responsibilities include collaborating with clinical and engineering teams to translate medical needs into technical solutions, implementing secure data handling practices, and guiding algorithmic strategy. The role is appealing due to its mission-driven environment where employees contribute directly to saving lives by expanding access to viable donor organs. The position offers opportunities for professional growth within a collaborative culture and includes limited domestic and international travel.

This full-time Cardiac Cath Lab Technician I role supports the Smidt Heart Institute at Cedars-Sinai Medical Center, a top-ranked facility in Southern California. The position involves assisting with over 8,000 annual diagnostic and interventional cardiovascular procedures across a twelve-laboratory facility. Key responsibilities include operating physiological monitoring systems to record ECG and hemodynamic data, managing sterile fields and equipment, and administering contrast agents while adhering to strict safety protocols. The role offers the appeal of working within a world-class team recognized for excellence in cardiology, providing opportunities for professional growth and exposure to complex cases ranging from neonates to geriatrics. This is a day shift position based on-site at the hospital.

This Dental Assistant role supports a team of dentists and lab professionals dedicated to delivering life-changing tooth replacement care. The position involves chair-side assistance for procedures such as dentures, implants, and oral surgery, alongside taking and developing x-rays. Key responsibilities include preparing the office for daily operations, assisting with patient impressions and wax bites, sterilizing instruments, and providing patient education on treatment options and aftercare. The role is appealing for its mission-driven focus on improving patient lives within a collaborative clinical environment. Candidates must hold active dental assistant and x-ray certifications with prior experience in dentures or implants. The position is based on-site with minimal travel required for training purposes.

The Quality Engineer role at Norman Noble involves supporting a team dedicated to manufacturing life-sustaining medical devices. Key responsibilities include leading process improvement projects, managing quality system documentation and records, and collaborating with customers and suppliers on validation activities and audits. The position requires analyzing data to drive decisions and ensuring compliance with industry standards like ISO 13485. This opportunity is appealing due to the company's entrepreneurial culture where individual contributions are highly visible, the access to state-of-the-art facilities, and the focus on continuous growth through high-tech problem-solving. The role is based on-site within the company's manufacturing facilities.

This Principal Investigator role leads clinical and scientific research within the Healthcare & Medical organization, focusing on home-based care for individuals with complex medical needs. Key responsibilities include designing research protocols, ensuring regulatory compliance with Good Clinical Practice, overseeing data integrity and analysis, and mentoring a multidisciplinary research team. The position involves collaborating with clinical operations to integrate findings into care models and authoring scientific publications. The role is appealing due to its mission-driven focus on improving patient outcomes for former energy workers, offering a collaborative and compassionate culture with robust training and clear pathways for career growth. The position requires occasional field visits to support care delivery environments.

The cGMP Sanitation Specialist role on the second shift focuses on maintaining hygiene and safety within a manufacturing facility, likely in the food, pharmaceutical, or biotech sector. Key responsibilities include performing routine and deep cleaning of production equipment and facilities, disassembling machinery for thorough sanitation, and accurately documenting all activities to ensure compliance with current Good Manufacturing Practices. The position requires adherence to strict safety protocols, proper handling of cleaning agents, and participation in regulatory audits. This opportunity appeals to detail-oriented individuals seeking a stable position in a regulated environment where maintaining product integrity is critical. The role involves working in controlled environments and may require physical effort, offering a chance to contribute to essential quality assurance processes.

The Quality Control Lead Engineer role at CTL Aerospace involves leading teams to ensure aircraft metal and composite components meet rigorous industry standards. Key responsibilities include directing quality control strategies, conducting root cause analysis for failures, managing supplier quality, and ensuring compliance with NADCAP and ISO regulations. The position requires bridging technical quality with business goals through data analysis and cross-functional collaboration with R&D and operations. This opportunity appeals to experienced professionals seeking a leadership position within a veteran-founded company with a long history in the aerospace sector. The role offers the chance to drive continuous improvement initiatives and mentor staff in a manufacturing environment while working with a collaborative team dedicated to high-quality engineering outcomes.

The Pharmacist in Charge role oversees pharmacy operations within a California facility, focusing on dispensing accuracy, patient consultation, and regulatory compliance. Key responsibilities include supervising pharmacy staff, managing training programs, ensuring adherence to state and federal laws, and supporting business growth initiatives. The position requires maintaining inventory security, handling controlled substances, and serving as the primary point of contact for internal and external inquiries. This opportunity appeals to experienced leaders seeking to drive quality patient care in a collaborative environment. The role involves a mix of on-site duties with an on-call rotation schedule, offering a chance to shape operational standards and mentor a dedicated team.

The Forklift Operator I role at Kenco Logistics involves safely operating powered industrial equipment to move, load, unload, and stack products within a warehouse setting. Key responsibilities include scanning items, printing labels, maintaining inventory records, and conducting daily safety inspections to ensure compliance with industry standards. This position offers a supportive environment that prioritizes employee growth, safety, and continuous improvement within a leading third-party logistics company. The role is based on-site with no travel required and operates during evening and night shifts.

The Dietary Aide role supports the kitchen and dining operations at Bear Creek Senior Living, a vibrant community within Stellar Senior Living in Colorado Springs. Team members assist the Dietary Manager with meal planning, prepare food alongside kitchen staff, and serve residents with professionalism while maintaining a clean dining environment. The position offers flexible full-time or part-time schedules, free meals during shifts, and opportunities for career growth through company-sponsored training and tuition reimbursement. This role appeals to those seeking a supportive, fast-paced environment where they can contribute to the well-being of seniors while working alongside a dedicated team.

This Director of Operations role leads manufacturing, supply chain, and quality functions for a global leader in precision power electronics and control systems based in Rochester. The position oversees end-to-end production processes including electronics assembly, testing, and box build while managing critical relationships with Tier 1 and Tier 2 suppliers. Key responsibilities include maintaining ISO and industry-specific certifications, implementing Lean and Six Sigma initiatives to drive efficiency, and leading cross-functional teams to ensure compliance with strict regulations in aerospace, medical, and semiconductor sectors. The role appeals to experienced leaders seeking a hands-on player-coach environment where they can directly influence operational excellence and product reliability. The position is primarily onsite with a mix of strategic planning and floor oversight, offering opportunities for professional growth within a high-reliability engineering culture.

This Registered Nurse role at Mission Hospital focuses on specialized vascular access and enteral nutrition care within a Magnet-designated tertiary care center. The position involves performing complex procedures such as PICC insertions using ultrasound, placing enteral feeding tubes, and managing central venous catheter maintenance and troubleshooting. The role appeals to nurses seeking professional growth through extensive mentorship, clinical education, and a nationwide transfer policy that supports long-term career advancement. The hospital offers a collaborative environment with comprehensive benefits, including tuition assistance and retirement matching, while providing flexible shift options to accommodate work-life balance.

This 13-week travel assignment places a Clinical Laboratory Scientist in Wrangell, Alaska, to support a local healthcare facility. The role involves conducting and overseeing complex laboratory tests across chemistry, hematology, microbiology, and blood banking while ensuring diagnostic accuracy and regulatory compliance. Key responsibilities include validating test results, maintaining sophisticated laboratory instruments, and mentoring staff. The position appeals to professionals seeking a mission-driven environment with comprehensive benefits, including day-one insurance and licensure reimbursement. The role offers the opportunity to work within a dedicated clinical team while contributing to patient care in a unique Alaskan setting.

This early-career Software Engineer role within Johnson & Johnson's Surgery team focuses on enhancing the cybersecurity of medical products in Santa Clara, California. The position involves designing and implementing software security controls, defining cybersecurity requirements, and conducting code and design reviews with a security focus. Key responsibilities include performing risk assessments to identify vulnerabilities, developing mitigation strategies, and writing C++ and bash scripts in a regulated environment. The role offers the appeal of contributing to life-saving surgical innovations while working in a collaborative, cross-functional setting. Although primarily onsite, remote work options may be considered on a case-by-case basis, and the position includes limited travel opportunities.

This early-career Software Engineer role within Johnson & Johnson's Surgery team focuses on enhancing the cybersecurity of medical products in Santa Clara, California. The position involves designing and implementing software security controls, defining cybersecurity requirements, and conducting code reviews with a security focus. Key responsibilities include performing risk assessments to identify vulnerabilities, developing mitigation strategies, and building C++ applications in a regulated environment. The role offers the appeal of contributing to life-saving surgical technologies while working in a collaborative, cross-functional setting. Although primarily onsite, remote work options may be considered on a case-by-case basis, and the position includes limited travel requirements.

This Dietary Aide role supports the kitchen and dining operations at Bear Creek Senior Living, a vibrant community within Stellar Senior Living in Colorado Springs. The position involves assisting with meal planning, preparing food alongside kitchen staff, and serving residents with professionalism in a 5-star dining environment. Key duties also include maintaining cleanliness and performing dishwashing tasks as needed. The role appeals to candidates seeking a supportive team culture focused on senior care, offering flexible full-time or part-time schedules, free meals during shifts, and opportunities for professional growth through company-sponsored training and tuition reimbursement. A food handler's permit and a positive attitude are required to thrive in this fast-paced setting.

The Product Development Engineer role at Top Shelf Manufacturing supports the design and production of orthopedic and sports medicine devices within the Tracy, CA office. The position leads the end-to-end product lifecycle from concept and prototyping through full-scale production, ensuring designs are manufacturable and cost-effective. Key responsibilities include managing cross-functional collaboration with operations and quality teams, driving Design for Manufacturability principles, and maintaining comprehensive documentation and bill of materials. The role appeals to candidates seeking a collaborative environment where they can mentor staff and drive continuous improvement in a growing company. The position is full-time with standard business hours and requires on-site presence at the facility.

This Dietary Aide role supports the kitchen and dining operations at Bear Creek Senior Living, a vibrant community in Colorado Springs. The position involves assisting with meal planning, preparing food alongside kitchen staff, and serving residents with professionalism in a 5-star dining environment. Key duties also include maintaining dining area cleanliness and performing dishwashing tasks as needed. The role appeals to candidates seeking a supportive team culture within a growing company that offers flexible full-time or part-time schedules, free meals, and opportunities for advancement through training and tuition reimbursement. A positive attitude and ability to work in a fast-paced setting are essential for this on-site position.