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.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Lead Auditor - Medical Devices (ISO 13485/MDSAP) in Cupertino, CA vacancy
- ...Primary Function of Position The Senior Mechanical Design Engineer... ...and recommendations. Lead mechanical engineering project... ...PhD. Direct experience in the medical device industry, with working knowledge... ...frameworks such as ISO 13485, FDA QSR, IEC 60601, ISO 149...SeniorMedical deviceFull timeLocal areaWorldwideFlexible hoursShift work
$150k - $165k
About Ceribell Ceribell is a medical technology company focused on... ...geometry for injection molding, lead tolerance stack-up analyses,... .../wearable electromechanical devices. * Experience with electromechanical... ...a regulated environment (ISO 13485) and familiarity with medical...SeniorMedical deviceFull timeLocal areaFlexible hours- ...Senior Regulatory Affairs Specialist Tiposi... ...and EU MDR pathways Lead preparation and submission... ...files per ISO 14971 and usability... ...interpret evolving global medical device regulations and... ...alignment with ISO 13485, MDR 2017/745, and... ...combination products MDSAP or ISO 13485...SeniorMedical device
Tiposi
Milpitas, CA19 hours ago $70 - $80 per hour
...activities in accordance with FDA and ISO regulations. This position is... ...on assay development in a medical devices or pharmaceutical industry... ..., and FDA regulations (ISO 13485, ISO 14971, FDA 21 CFR 820... ...products utilizing PCR (preferred). Seniority level Seniority level Mid-...SeniorMedical deviceFull timeContract workWork experience placementDay shiftKelly Science, Engineering, Technology & Telecom
Sunnyvale, CA19 hours ago$90k - $180k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...The Opportunity As a Senior Product Development Engineer... ..., FDA regulations, ISO standards, and... ...(21 CFR Part 820), ISO 13485, and applicable medical...SeniorMedical deviceFull timeWorldwideShift workAbbott
Santa Clara, CA1 day ago$125k - $201.25k
...is recruiting for a Senior Quality Engineer,... ...collaborate on breakthrough medical technologies that... ...development. Lead and execute design... ...Practices), ISO (International Organization... ...in medical device industry or other highly... ...regulations such as ISO 13485, ISO 14971, IEC 60...SeniorMedical deviceWork experience placementWork at officeLocal areaImmediate startJ&J Family of Companies
Santa Clara, CA19 hours ago$125k - $145k
...teams and leadership. Lead the preparation of all... ...establishment registrations and device listing per applicable... ...external audits (FDA, MDSAP, EU MDR, UKCA, etc.) to... ...limited to 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR,... .... Strong knowledge of medical device labeling...SeniorMedical deviceWork experience placementWork at officeWork visaNight shiftWeekend work3 days per week$135.5k - $216.8k
...possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the... ...and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, Canadian MDR, Japan PMDA as well...SeniorMedical deviceHourly payFull timeWorldwideShift work$224k - $356.5k
Senior Software Architect, DriveOS page is loaded## Senior Software Architect, DriveOSlocations... ...certified for both automotive safety (ISO 26262 ASIL-D) and cybersecurity (ISO 214... ...including robotics, avionics, and medical devices.We're looking for a strong technical leader...SeniorMedical deviceWork experience placementNVIDIA Corporation
Santa Clara, CA19 hours ago- ...Senior Quality Engineer We are seeking an experienced... ...with expertise in Medical Device Quality Engineering and... ...with FDA regulations, ISO standards, and global medical... ...Responsibilities Lead design transfer and... ...FDA regulations and ISO 13485 requirements. Support...SeniorMedical device
Katalyst HealthCares & Life Sciences
Santa Clara, CA4 days ago - ...Part Qualification efforts. Lead Core Product Teams in... ...assessments, supporting lead auditors in QMS evaluations. Support... ...Familiarity with 21 CFR Part 820 and ISO 13485; experience auditing... ...methods. ~ Experience in a medical device company preferred. ~ Experience...SeniorMedical device
Katalyst HealthCares & Life Sciences
Sunnyvale, CA19 hours ago $105.66k - $124.31k
...global distribution network supporting a medical device manufacturing organization. This... ...System Regulation (21 CFR Part 820) ISO 13485 SOX requirements Internal Quality... ...performance. Continuous Improvement Lead inventory improvement initiatives. Identify...SeniorMedical deviceWork experience placementWork at officePROCEPT BioRobotics
San Jose, CA19 hours ago- ...Description About us: For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive... ...Knowledge of Medical Device regulations (ISO 13485 and FDA 21CFR820). Strong computer skills, including...SeniorMedical deviceHourly pay
Cirtec Medical
Santa Clara, CA4 days ago - ...early-stage, pre-commercial medical device company with a vision for Physical... ...Technology is seeking a Senior Systems Engineer with a strong... ...hardware and software teams Lead the development of risk-based... ...and regulations, such as: ISO 13485, ISO 14971, IEC 60601 (system...SeniorMedical device
- ...ensuring quality and compliance within the medical device industry, specifically for a surgical... ...standards. Key Responsibilities: Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing...Medical device
Prophecy Technologies
Santa Clara, CA2 days ago - ...Senior Biostatistician As a key member of the Clinical... ...statistical lead, providing technical leadership... ...journals, and medical conferences. Explore novel... ...Clinical Practice (GCP), ISO 14155, and 21 CFR Part... ...trials, surgical medical device clinical research strongly...SeniorMedical deviceLocal areaRelocationFlexible hours
Intuitive
Sunnyvale, CA4 days ago - ...documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment.... ...compliance with FDA regulations and ISO standards. Collaborate with... ...Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP)....Medical device
Katalyst Healthcares and Life Sciences
Sunnyvale, CA3 days ago - ...Systems from product concept through market launch. The Senior Mechanical Engineer will design medical capital equipment components for volume manufacturing... ...Robot design experience. Surgical or medical device product experience is a plus. Comfortable with all phases...SeniorMedical deviceFull timeWork experience placementLocal areaWorldwideFlexible hoursShift work
- ...Description Primary Function of Position As a Senior Electrical Engineer, you will design and... ...technical depth, a record of successful medical product development, and a collaborative,... ...Preferred Skills & Experience Medical device product development experience....SeniorMedical deviceFull timeLocal areaWorldwideFlexible hoursShift work
$50 per hour
...Qualifications 2–5 years in Supplier Engineering or Quality Engineering (medical device or capital equipment preferred). BS in Engineering (Master’s... .... Strong problem-solving curiosity and communication skills. Seniority Mid-Senior level Employment type Contract Job function...SeniorMedical deviceContract workWork at officeDGN Technologies
Sunnyvale, CA1 day ago$90k - $180k
...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our... .... JOB DESCRIPTION: About the Role This Senior Site Reliability Engineer position works on-site...SeniorMedical deviceFull timeRemote workShift work$78 - $83 per hour
...Overview Senior Systems Process Engineer — Palo Alto, CA — Duration: 5 month contract... ...Mobility, aerospace, space systems, or medical devices is highly valued—particularly where agile... ...Expert knowledge of UNECE R156 (SUMS) and ISO 26262, with demonstrated experience implementing...SeniorMedical deviceContract workHydrogen Group
Palo Alto, CA1 day ago- ...vascular interventional catheter device design, development, and... ...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...SeniorMedical deviceFull timeLocal areaRelocationVisa sponsorship
- ...diversity of thought and mutual respect. We lead with inclusion and empower our team... ...stages, sensors, safety systems and other devices as part of the overall test system Coordinate... ...software systems Experience in medical device manufacturing or a regulated engineering...SeniorMedical deviceFull timeLocal area
Intuitive
Sunnyvale, CA19 hours ago - ...project, you will join a small team of experts in medical imaging, robotics, and software. You will play a lead technical role, working to conceptualize,... ...insights toolkits • Project experience in medical devices or another regulated industry Additional Information...SeniorMedical deviceFull timeLocal areaWorldwideFlexible hours
Intuitive & Co
Sunnyvale, CA19 hours ago $160k - $190k
...Applied Intuition is seeking a Risk and Compliance Lead in Sunnyvale, CA. This role involves leading security compliance initiatives and managing the security GRC program. The ideal candidate has over 6 years of experience in risk management and must be comfortable presenting...SeniorApplied PC
Sunnyvale, CA4 days ago$119.2 - $132.45 per hour
...Senior Internal Auditor Key Details Location: Sunnyvale, CA 94086 Duration: 6 months, with potential extension Schedule: Hybrid schedule with onsite work Tuesday through Thursday Work Arrangement: Hybrid Compensation: $119.20-$132.45...SeniorHourly payIcon Information Consultants
Sunnyvale, CA1 day ago$133.4k - $222.3k
...Stryker is hiring a Senior Staff Quality Engineer for our Endoscopy... ...and processes. Advocate and lead the execution of initiatives... ...Development (R&D) within the medical device industry, supporting product... ...requirements, including ISO 13485, Good Documentation Practices...SeniorMedical deviceFull timeLocal area- ...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
$122.5k - $157.5k
...Join to apply for the Senior Manufacturing Engineer role at EBR Systems, Inc. Overview The Senior Manufacturing Engineer will contribute... ...Biomedical engineering. Minimum of 8 year of experience with medical device manufacturing experience. Can be an equivalent combination of...SeniorMedical deviceContract workImmediate startNight shiftEBR Systems, Inc.
Sunnyvale, CA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Lead Auditor - Medical Devices (ISO 13485/MDSAP). Be the first to apply!
Related searches
- medical claims auditor Cupertino, CA
- senior medical science liaison Cupertino, CA
- senior storage engineer Cupertino, CA
- senior vice president of operations Cupertino, CA
- senior level Cupertino, CA
- senior vmware engineer Cupertino, CA
- senior cybersecurity engineer Cupertino, CA
- srs Cupertino, CA
- senior manager legal Cupertino, CA
- senior performance tester Cupertino, CA