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$146.3k - $244.1k
...Senior International Quality and Regulatory Compliance Associate... ...committing to the values that lead to great work. Every new product... ...on international/OUS/ROW medical device projects in either a quality... ...Quality Management Systems (QMS), ISO 13485, and international quality...SeniorMedical deviceRelocation$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- A tech company in California is seeking a Senior Auditor to support SOX compliance and conduct internal audits. The ideal candidate should... ...US GAAP. Responsibilities include planning SOX compliance, leading audits, and collaborating with various teams to ensure proper...Senior
$145k - $167k
...Job Title : Senior Regulatory Affairs... ...for the company's devices and ensures compliance... ...leadership. Lead the preparation of... ...audits (FDA, MDSAP, EU MDR, UKCA, etc... ...limited to 21 CFR 820, ISO 13485, MDSAP, EU MDD/... ...Strong knowledge of medical device labeling...SeniorMedical deviceWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week- 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
- 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
- ...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
- ...vascular interventional catheter device design, development, and... ...a highly motivated, hands‑on Senior Medical Device R&D Engineer to support... ...Roles and Responsibilities Lead technical projects related to... ...Strong working knowledge of ISO 13485 regulated Design Controls Experience...SeniorMedical deviceLocal areaRelocationVisa sponsorship
- ...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 analysis... ...regulations, such as: ISO 13485, ISO 14971, IEC 60601...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
- ...paralysis operate digital devices using only their... ...research into real‑world medical solutions. As a Precision... ...human trials with leading hospitals across the country... ...future of our field. Senior Staff Electrical Engineer... ...Systems under ISO 13485 gained through at least...SeniorMedical deviceContract workWork experience placementWork at officeRemote work
- A leading medical device company in San Jose seeks a Senior Demand and Supply Planning Manager. This role involves leading planning, forecasting, and supply balancing for both domestic and international operations. Ideal candidates will have over 12 years of experience...SeniorMedical device
- ...Human Factors Manager to guide the human factors strategy and lead a team of engineers. This role involves overseeing project execution... ...degree in relevant fields and 5-7 years of experience in the medical device industry, with proven leadership in complex human factors...SeniorMedical device
$152.2k - $209.35k
...Technology, Inc. is seeking a Senior Materials Engineer with... ...composite and adhesive, and medical device packaging to lead complex, cross‑functional initiatives... ...in accordance with ISO 11607 and ASTM/ISTA... ...processes in accordance with ISO 13485 and FDA QSR requirements....SeniorMedical device- Align Technology, Inc. in San Jose, California is seeking a Quality Inspector to ensure the quality of medical devices. This role requires early to mid-level quality professionals to perform in-process and final inspections while adhering to Good Documentation Practices...Medical deviceContract work
- ...for a Staff Clinical Development Engineer - Incubator who will lead clinical development efforts and execute evaluation strategies... ...projects. This position requires 10+ years of experience in medical device development and strong collaboration skills. The role involves...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
$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$136.1k - $195.9k
...seeking a Mechanical Engineer in Sunnyvale, California, to design and construct manufacturing equipment for minimally invasive medical devices. Responsibilities include prototyping, ensuring safety and validation of designs, and managing project plans. The ideal candidate...SeniorMedical device$53.98 - $71.57 per hour
Stanford Children's Health | Lucile Packard Children's Hospital Stanford is seeking a Senior Payroll Auditor & Quality Assurance to ensure accuracy, compliance, and integrity in payroll data. This role involves conducting audits, analyzing data trends, and collaborating...SeniorHourly pay$120k - $144k
...treated? Join us as a Senior Regulatory Affairs Specialist... ...regulatory science for medical robotics. Your mission?... ...Class II and III devices and preparing and submitting... ...Involve: Act as a lead regulatory... ...requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive...SeniorMedical devicePermanent employmentTemporary workLocal areaFlexible hours- A cutting-edge medical device company in Sunnyvale is seeking a Research Associate III / Scientist I with extensive bioengineering skills in microfluidics and assay development. The role involves designing microfluidic systems, collaborating with interdisciplinary teams...SeniorMedical device
- ...skills include managing submissions and understanding design controls. Ideal candidates will have a minimum of 5 years in the medical device industry. This position supports innovation in robotic-assisted surgery and comes with a competitive salary package. #J-18808-Ljbffr...SeniorMedical device
- ..., Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance... ...knowledge of 21 CFR part 820 and ISO 13485 Significant computer experience using... ...suppliers Experience in a high-volume medical device company is a plus Ability to read and...SeniorMedical deviceContract workLocal areaWorldwideFlexible hours
$79k - $86k
...through thorough inspections and testing, requiring a minimum of four years of quality control experience in the medical device industry. Proficiency in FDA and ISO standards is essential. Employee benefits include stock options, competitive salaries, a 401k plan, health...SeniorMedical device$94k - $118k
...Kingdom. It is supported by leading global investors and... ...Quality System for medical device processes. This... ...and recommendations to senior management. These... ...requirements, including ISO 13485, ISO 14971, 21 CFR 82... ...ASQ Certified Quality Auditor, Certified Quality Engineer...SeniorMedical deviceFull timeWork at officeLocal areaRemote workFlexible hours- A medical device leader is seeking a Senior Supplier Quality Engineer to ensure suppliers meet quality, service, and delivery requirements. The role involves driving process improvements and supporting new product introductions in a fully onsite position. Candidates need...SeniorMedical device
- Akraya, Inc. is seeking an experienced Senior Technical Writer for their Sunnyvale, CA location. In this role, you will create and maintain high-quality hardware documentation for complex medical devices, ensuring compliance with industry standards. Your responsibilities...SeniorMedical device
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