Quality Systems Leader - Medical Devices
SupportFinity™
AliveCor is seeking a QA leader to oversee medical device development and commercialization, ensuring the QMS stays compliant with global requirements including MDSAP and EU MDR. You will collaborate across Regulatory, Product Management, and Marketing to maintain high safety and quality standards. This role requires 4–6 years in medical device quality systems, strong documentation practices, and a proven ability to drive process improvements across cross-functional teams. #J-18808-Ljbffr SupportFinity™
- ...partner by enabling access to quality heart care for everyone.... ...pioneered over-the-counter medical ECG devices and continues to lead the way... ...ensure our Quality Management System remains compliant with global... ...for a detail‑oriented leader dedicated to maintaining the...QualityMedical deviceWork experience placement
$144k - $209k
...Operations, a related technical field, or equivalent practical experience. 8 years of experience in quality engineering or systems architecture for software as a medical device or digital health products. Experience in ISO 13485, ISO 14971, and IEC 62304 requirements and...QualityMedical deviceShift work$144k - $209k
About the job The Digital Health Regulatory Quality and Strategy (DHRQS) team serves as the... ...14971 as they apply to software as a medical device and artificial intelligence products. Preferred... ...Run the Quality Management System (QMS) process, ensuring evidence collection...QualityMedical device- ...do at Intuitive . As a global leader in robotic-assisted surgery... ...technologies—like the da Vinci surgical system and Ion —have transformed how... ...maintaining high levels of quality and effectiveness Experience... ...required Experience with medical devices and FDA-regulated environment...QualityMedical deviceFull timeLocal areaWorldwideShift work
- ...A technology company is seeking an experienced FW Testing professional in Sunnyvale, CA, to contribute to embedded systems and medical devices projects. Candidates must have strong skills in VC++, MFC, API testing, and knowledge of visual studio developments. This is a...Medical device
$190k - $284k
...commercially minded industry leader who can bring together... ...healthcare‑focused consultants, systems integrators, developers, software... ..., and strengthen execution quality in the field. Own healthcare... ...technology, digital health, medical devices, enterprise software, or...QualityMedical deviceLocal areaRemote work- ...do at Intuitive . As a global leader in robotic-assisted surgery... ...technologies‑like the da Vinci surgical system and Ion ‑have transformed how... ...initiatives across a global medical device organization. This is a... ...MDR, ISO 13485, and company quality standards. Lead system...QualityMedical deviceContract workLocal areaWorldwideFlexible hoursShift work
- ...do at Intuitive . As a global leader in robotic-assisted surgery... ...- like the da Vinci surgical system and Ion —have transformed how... ...global delivery of regulated medical device content. This role is responsible... ...CMS platforms, ensuring high-quality, compliant, and scalable...QualityMedical deviceWork experience placementLocal areaWorldwideFlexible hoursShift work
$228.1k - $393.8k
...looking for a Senior Manager of Product System Test in Cupertino, California. This pivotal role requires a strong leader who will oversee all aspects of Quality Engineering within the Wireless... ...and benefits include comprehensive medical coverage, retirement benefits, and...Quality- Position: Manager - IT Business Systems Quality Location: Redwood City, CA Job Id: 249-113... ...compliance Partner with functional business leaders to understand their technology needs... ...Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of...QualityMedical device
- ...client is a well-established and growing medical device manufacturer located in Palo Alto, CA. They are committed to producing high-quality, precision-engineered products that meet... ...inspections Ensure compliance with quality system requirements (ISO and FDA standards)...QualityMedical device
- Kelly Services, the industry leader in manufacturing and technical... ...with a global leader in the medical device and pharmaceutical industries... ...located in Santa Clara, CA. The System Verification Project Manager... ..., resource coordination, quality activities, and testing readiness...QualityMedical deviceWork at officeLocal areaRemote work
- ...in ensuring compliance with regulatory standards and leading quality-focused initiatives across product development. The ideal candidate... ...have a strong background in Quality and Design Assurance in medical devices, a Bachelor’s degree in Engineering, and demonstrated...QualityMedical device
- ...Manager to lead Design Assurance initiatives. This role focuses on quality-focused decision making and ensuring regulatory compliance in... .... The ideal candidate will have significant experience in medical device quality assurance, supporting new product development and...QualityMedical device
- ...involves managing the development and global delivery of regulated medical device content while ensuring compliance with industry standards.... ...leadership, collaboration, and process improvement for high-quality content delivery. #J-18808-Ljbffr Intuitive Surgical, Inc.QualityMedical device
$19.5 - $35 per hour
...leading innovator in ultrasound device design and manufacturing, serving predominantly the medical device industry. We are a... ...electronics, electro-mechanical systems, measurement devices—scientific... ...production schedules Performing Quality Assurance measurements and inspection...QualityMedical deviceFull time- ...major aerospace and defense company in Sunnyvale, California, is seeking a Quality Engineer to lead the implementation of program quality requirements. The role involves managing quality systems, conducting audits, and ensuring compliance with quality standards throughout...Quality
$146.3k - $244.1k
...candidates should possess over 5 years of experience with Quality Management Systems and relevant regulatory knowledge. The role offers competitive... ...includes various employee benefits such as stock options, medical coverage, and educational reimbursements. #J-18808-Ljbffr...QualityMedical device$146.3k - $244.1k
...is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate about the health space... ...based role. Responsibilities Subject matter expert on the quality management system audit processes Independently supports internal audit program...QualityMedical deviceRelocation$25 - $31 per hour
...actively seeking an Inventory Lead to join a medical device and biotech manufacturer that supports... ...efficiency. Be part of a stable, quality-focused organization that values proactive... .... Record receipts in the ERP system and assign internal lot or batch identification...QualityMedical deviceHourly payTemporary workLocal areaMonday to Friday$207k - $300k
...experience working with embedded operating systems. 3 years of experience with software... ...delivering embedded system software for consumer devices. Experience in hardware/software debug... ...to be versatile, display leadership qualities and be enthusiastic to take on new...QualityFull time- ...recruitment, development of wireless algorithms, and overseeing the quality and performance of projects from concept to mass production.... ...management experience and 7 years in wireless communications systems. You will ensure the team's performance and quality standards while...Quality
- The Receiving Inspection Quality Inspector ensures that all incoming materials, components... ...inspection results in the ERP/QMS system. Approve compliant materials for inventory... ...preferably in a manufacturing, aerospace, medical device, or automotive environment. Ability to...QualityMedical device
- ...audit process, and preventive actions for risks. Supporting quality system integration for acquisitions and new product introductions.... ...Affairs & Quality Systems experience. Hands‑on exposure to medical device regulations (US FDA, CE), QMS processes (change management,...QualityMedical device
$60.62 - $68.72 per hour
...; clinics; laboratories; and medical equipment distribution areas.... ...support a wide variety of medical devices in use at an academic medical... ...and adherence to safety and quality programs, sustaining... ...organization. Knowledge of computer systems and software used in...QualityMedical deviceHourly payWork experience placementShift work$214k - $356.6k
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States Hardware The Health group is looking for an International... ...in settling and communicating appropriate regulatory/quality strategy, actions and requirements, while overseeing a team...QualityMedical deviceRelocation$20 - $23 per hour
...Duties and Responsibilities Follow detailed Quality Assurance inspection procedures Perform... ...and maintenance of Quality Systems/ other Quality Assurance activities Perform... ...equivalent (preferred) Experience in a medical device or pharmaceutical company.(preferred) Experience...QualityMedical deviceFull timeTemporary workWork at officeLocal area$112k - $120k
...Purpose of Job The Quality Assurance (QA) department is committed... ...including laser consoles, delivery devices, and accessories. In this... ...validations in a regulated medical device environment. Major Duties... ..., and software-integrated systems. Lead root cause investigations...QualityMedical device- ...to own the user experience from end-to-end and elevate product quality. This role requires strong product taste, visual design skills,... ...drive UX decisions, enhance product clarity, and define design systems, all while collaborating closely with the founding team and engineering...Quality
$90.9k - $122k
...Fisher Scientific in ensuring the highest quality standards across our operations. As a... ...continuous improvement of quality systems that enable our customers to make the world... ...regulated industries (pharmaceutical, medical device, or biotech preferred) Experience with...QualityMedical deviceTemporary workWork at officeRelocation package
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