Senior Lead Auditor - Medical Devices (ISO 13485/MDSAP)
$146.3k - $244.1kApple Inc.
A leading technology company in Cupertino is seeking a Senior Lead Auditor to support their healthcare product line. In this role, you will lead internal and supplier audits to ensure compliance with regulatory standards. Ideally, candidates should possess over 5 years of experience with Quality Management Systems and relevant regulatory knowledge. The role offers competitive compensation ranging from $146,300 to $244,100 and includes various employee benefits such as stock options, medical coverage, and educational reimbursements. #J-18808-Ljbffr Apple Inc.
$146.3k - $244.1k
..., committing to the values that lead to great work. Every new product... ...The Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate... ...audits in accordance to ISO 13485, MDSAP requirements, China GMP, EU MDR...SeniorMedical deviceRelocation$109k - $174.8k
Johnson & Johnson is seeking a Senior Quality Engineer in Santa... ...quality engineering oversight in medical device manufacturing. The role requires... ..., with expertise in ISO 13485 and risk management. Key responsibilities include leading quality projects, reviewing compliance...SeniorMedical deviceFull time- Intuitive is seeking a Medical Device Packaging Design Engineer in Sunnyvale, California. This critical role involves the design and development... ...stringent regulatory standards. Responsibilities include leading testing and validation efforts, collaborating with various...SeniorMedical device
$92.7k - $152.9k
Dart Solutions is seeking a Senior International Regulatory Affairs Specialist based in Milpitas... ...global commercialization of diagnostic devices by managing regulatory submissions.... ...degree and significant experience in the medical device or diagnostics industry. The position...SeniorMedical device$214k - $356.6k
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States Hardware The Health group is looking for an International... ...expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product-specific standards...Medical deviceRelocation- ...of Position: The Senior Project Manager - Instruments... ...is responsible for leading and executing the full... ...development lifecycle of medical device instruments and... ...including FDA, EU MDR, ISO standards, and relevant... ...pathways (FDA, EU MDR, ISO 13485), submission requirements...SeniorMedical deviceLocal areaWorldwideFlexible hours
$162k - $186k
...Senior Manager, Regulatory Affairs Guilford, Connecticut... ...'s Class II MRI devices and Class I accessory... ...: Develop and lead regulatory strategies... ...and inspections (e.g., ISO 13485/MDSAP, FDA) and to maintain... ...Class I and Class II medical devices (preferably imaging...SeniorMedical deviceWork at officeWork visaShift workNight shiftWeekend work3 days per week$91k - $147.2k
6947-SHOCKWAVE MEDICAL INC. Legal Entity is seeking a Sr. Site Transfer Manufacturing Engineer to lead and execute product and process transfers across manufacturing sites. This... ...environments, particularly in medical devices. Benefits include vacation, sick time, and...SeniorMedical device- A leading staffing company is seeking an experienced regulatory professional for their Companion Diagnostics team. The ideal candidate... ...will have extensive global regulatory experience in IVDs and medical devices, leading successful submissions and working directly with...SeniorMedical device
$78k - $156k
...Senior Auditor, Global Compliance Audit Abbott is a global healthcare leader that helps people live more... ...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines....SeniorMedical deviceRotational programWork experience placementLocal areaWorldwide- A well-established medical device manufacturer is seeking a Senior Quality Inspector in Palo Alto, CA. Responsibilities include performing complex inspections... ...years of inspection experience, strong knowledge of ISO 13485 and FDA regulations, and proficiency in various...SeniorMedical device
$138k - $154k
...Ceribell Ceribell is a medical technology company focused on... ...Engineer to join our team! The Senior Electrical Engineer will... ...design of next-generation medical devices. The ideal candidate will... ...particular familiarity with ISO 13485, IEC 60601, MOPP, and MOOP....SeniorMedical deviceFor contractorsLocal areaFlexible hours3 days per week- ...throughput wireless system for the company’s device to interface directly with computers.... ...experience as an electrical engineer working on medical devices. Demonstrated ability designing,... ...with Quality Management Systems under ISO 13485 (2+ years of experience). Demonstrated...SeniorMedical deviceContract work
- ...Technology is seeking a Senior Systems Engineer with a... ...of our next-generation medical imaging platforms. This... ...and software teams Lead the development of risk... ...for regulated medical devices Contribute to failure... ...regulations, such as: ISO 13485, ISO 14971, IEC 60601...SeniorMedical device
- ...artificial intelligence, medical imaging, and next-generation... ...We are looking for a Senior Electrical Engineer to build... ...Responsibilities Lead the design, development,... ...with regulated medical-device hardware development (IEC 60601, ISO 13485, FDA), or willingness to...SeniorMedical device
- ...in internal and external audits (e.g., ISO 13485, MDSAP) as process owner for areas including... ...effective in resolving underlying issues Lead a multi-functional team including... ..., FDA QSR, and audit expectations for medical device manufacturers Proven ability to...SeniorMedical device
- ...Description Primary Function of Position The Medical Device Packaging Design Engineer is a critical... ..., functional, global regulatory (FDA, ISO 11607, EU), and quality requirements. The... ...Duties Design, Development, and Verification Lead the design, optimization, verification (...SeniorMedical device
$282.88k - $295k
Return to jobs list Senior Staff Electrical Engineers... ...operate digital devices using only their thoughts... ...research into real‑world medical solutions. As a Precision... ...human trials with leading hospitals across the country... ...Systems under ISO 13485 Demonstrated ability...SeniorMedical deviceFull timeContract workRemote work- ...artificial intelligence, medical imaging, and next-... ...We are looking for a Senior Optical Engineer to build... ...Responsibilities Lead the design, simulation,... ...record of building optical devices from prototype through... ...(IEC 60601, ISO 13485, FDA) and laser safety...SeniorMedical device
- ...artificial intelligence, medical imaging, and next-generation... ...We are looking for a Senior Machine Learning Engineer... ...that runs on real wearable devices. Responsibilities Lead the design, training, and... ...(FDA SaMD, IEC 62304, ISO 13485), or willingness to learn...SeniorMedical device
- ...Care seeks a Sr. Data Analytics & Business Insights Manager to lead the development of analytics capabilities in Campbell,... ...have over 12 years of experience in analytics, preferably in the medical device or healthcare industries. Responsibilities include defining KPI...SeniorMedical device
- Intuitive is seeking a Senior Mechanical Engineer to support their New Product Development team focused on robotic-assisted platforms in China. This role involves collaborating with design teams and regulatory bodies to ensure successful product launch and compliance....SeniorMedical device
$140k - $160k
...fast-growing, publicly traded medical device company that is an industry... .... Project Manager/ Senior Project Manager Location:... ...stage to launch, including leading cross-functional meetings outside... ...regulations (e.g. FDA QSRs, ISO 13485 or ISO 14971), the employee...SeniorMedical deviceLocal areaRemote workWorldwide$160k - $185k
Human Factors Engineer Lead - Sunnyvale, CA Lead the Human Factors Engineering & Design... ...preferred, especially with a focus on medical devices or diagnostics. Human Factors & Risk Analysis... ...into risk management processes per ISO 14971. Experience leading formative and...Medical device- ...Senior Project Manager, Clinical Affairs It started with a simple... ...brings deep familiarity with medical device development lifecycle as well... ...risk registers, and leading detailed project reviews to drive... ...requirements (e.g., FDA, EU MDR, ISO 14155, ICH GCP)...SeniorMedical deviceLocal areaWorldwide
$119k - $177k
...over 7 years of experience in mechanical design, specifically in high-volume medical devices, and proficiency in CAD tools like Solidworks. This hybrid role includes responsibilities such as leading projects, designing mechanical systems, and collaborating with various...SeniorMedical device- ...mechanical design engineer in Sunnyvale, California. The role requires leading multi-disciplinary teams, developing full-scale prototypes, and... ...decisions under time constraints. Join us to contribute to innovative medical capital equipment projects. #J-18808-Ljbffr IntuitiveSeniorMedical device
- ...Intuitive in Sunnyvale is seeking a Senior Project Manager for Clinical Affairs to oversee project planning, coordinate activities... ...timely deliverables. This role requires a strong background in medical device development and clinical lifecycle management, as well as excellent...SeniorMedical device
- ...-precision, detail-oriented Senior Project Engineer to perform... ...focused on the management of the medical device product journey : from the... ..."glue" between the Technical Lead and the clinical site,... ...documentation complies with ISO 13485 and FDA 21 CFR 820. You are...SeniorMedical deviceLocal areaWorldwideFlexible hours
- ...Senior Manufacturing Engineer - Wire Stranding It started with... ...of stranded wire cables. Lead project management of engineering... ...programming a plus ~ Medical device manufacturing experience a plus... ...designs ~ Experienced in ISO9001/13485, or medical device...SeniorMedical deviceLocal areaRemote workWorldwideFlexible hoursShift work
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