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- ..., committing to the values that lead to great work. Every new product... ... Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate... ...device regulatory requirements (e.g. ISO 13485, MDSAP requirements, China GMP, EU MDR,...SeniorMedical device
$145.21k - $155.37k
...Senior Quality Engineer Location: Santa Clara, CA; Type: Full‑time... ...efficiently deliver safe and effective medical device designs for manufacturing.... ...compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable...SeniorMedical deviceFull timeLocal areaImmediate start- ...Function of Position The Senior Manager of Instruments... ...instruments. They lead multiple design teams and... ...Research, Clinical and Medical Affairs, Process Development... ...as described in ISO 13485, ISO 14971 and FDA Quality... ...requirements for reusable medical devices and applicable...SeniorMedical deviceLocal areaFlexible hoursShift work
$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$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
- ...cost, and service. Essential Job Duties Lead Part Qualification activities in support... ...Skills and Experience Experience in a medical device company Experience with low-volume high... ...Familiarity with 21 CFR part 820 and ISO 13485 Experience in auditing suppliers to these...SeniorMedical deviceLocal areaFlexible hours
- 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
- ...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
$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- ...Primary Function of Position The Senior Manager, Technical Services... ...Support teams. This role leads a team of business systems professionals... ...initiatives across a global medical device organization. This is a... ..., including FDA, MDR, ISO 13485, and company quality standards...SeniorMedical deviceContract workLocal areaWorldwideFlexible hoursShift work
$138k - $154k
About 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$32 - $36 per hour
...Description: Quality Inspection Lead Full-time | Permanent |... ...About Us: Vantedge Medical is the premier metals-based med... ...quality control within medical devices, precision machining, or other... ...quality system requirements such as ISO 13485 and/or ISO 9001. ~ Preferred...Medical deviceHourly payPermanent employmentFull timeDay shift$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- ...development programs The Senior Manager establishes... ...Design Assurance personnel Lead Design Assurance... ...progressive experience in medical device Quality and/or Design... ...21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 20... ...degree preferred. Lead Auditor certification preferred...SeniorMedical device
$109k - $174.8k
...are searching for the best talent for a Senior Post Market Surveillance Specialist to... ...product surveillance activities for all medical devices manufactured, marketed, distributed,... ...0), EU Medical Device Regulations, and ISO 13485 standards. Excellent written and verbal...SeniorMedical deviceLocal areaImmediate start- ...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
- Imperative Care in Campbell, California, is looking for a Senior Manager to lead Design Assurance initiatives. This role focuses on quality... .... The ideal candidate will have significant experience in medical device quality assurance, supporting new product development and...SeniorMedical device
- Imperative Care is seeking a Senior Manager in Design Assurance located in Campbell,... ...compliance with regulatory standards and leading quality-focused initiatives across... ...background in Quality and Design Assurance in medical devices, a Bachelor’s degree in Engineering,...SeniorMedical device
$109k - $174.8k
...searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation & Accessories... ...feedback for specifications, device testing, risk management, and other... ...Regulatory Affairs experience within Medical Device is required (4+ years with...SeniorMedical deviceFull timeWork at officeLocal areaImmediate startRelocation packageFlexible hours3 days per week- ...Affairs department, the Senior Biostatistician (... ...independent 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...SeniorMedical deviceLocal areaWorldwideRelocationFlexible hours
$24 - $26 per hour
...Senior SMT Quality Control Lead Location: Silicon Valley, CA Schedule: Full-Time | 1st Shift Pay: $24-$26... ...Aerospace electronics manufacturing experience Medical device manufacturing experience ISO 9001 and/or ISO 13485 experience Previous leadership or QC...SeniorMedical deviceLong term contractFull timeWork at officeDay shift- ...seeking a Principal Regulatory Affairs Associate for their health products team. This role involves leading regulatory initiatives to obtain approvals for innovative medical devices, requiring 10+ years of medical device regulatory experience and a B.S. in Engineering. The...Medical device
- iSono Health Inc. in Sunnyvale is seeking a Senior Manufacturing Engineer to oversee... ...operations. You will define manufacturing KPIs, lead scale-up operations, and ensure... ...candidate has 5+ years of experience in medical device manufacturing, a strong foundation in design...SeniorMedical device
$79k - $86k
...Bring A minimum of 4 years of quality control experience in the medical device industry; or equivalent combination of education/training and... ...quality system requirements (FDA 21 CFR Part 820 and/or ISO 13485), as they relate to quality control processes and good manufacturing...SeniorMedical deviceFull timeWork experience placement- ...scalable, capable supplier processes. Medical device manufacturing experience is... ...quality, and business objectives. Lead supplier capability assessments... ...and operations. Understanding of ISO‑based quality systems (e.g., ISO 9001, ISO 13485) and their practical application...SeniorMedical deviceLocal areaShift work
$150k - $190k
...development of innovative devices for both large,... ...stage start-ups in the medical industry. The medical systems... ...seeking a hands-on Senior Mechanical R&D Engineer... ...Standards from ANSI/AAMI, ISO, ASTM, ASME, and the... ...international standards such as EN 13485 and ISO 14971, etc....SeniorMedical deviceFull timeFlexible hours- ...Six Sigma, Lean, SPC, and negotiation. Lead these efforts without managerial guidance... ...and SAP Knowledge of 21 CFR part 820 and ISO 13485 preferred Excellent written and verbal... ...executives Experience in a high‑volume medical device company is a plus Ability to travel to...SeniorMedical deviceContract workLocal areaWorldwide
- Radiant Systems Inc is looking for a Senior Materials Planner IV in Sunnyvale, CA. This position requires expertise in material planning and MRP systems for a Major Medical Device Client. The planner will coordinate engineering change orders and manage material planning...SeniorMedical device
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