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Manufacturing Engineering QA Manager ensuring end-to-end quality and regulatory compliance (ISO 13485, MDR, MDSAP, FDA) across medical device manufacturing processes, including design transfer, process validation, FMEA, and CAPA.
Ensures compliance with medical device regulations (e.g., FDA, EU MDR) for cochlear implant software/hardware design, leading testing, risk analysis, and cross-functional teams to meet safety and quality standards.
At Sonova, everything we build ultimately serves one purpose: improving the lives of people with hearing impairments. Behind every system, process, and release, there is a person who relies on our technology to…
Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our…
Software Verification Manager, Medical Software Valencia, California – REMOTE Join a global leader in medical technology where innovation, quality, and patient impact come together. We are seeking an experienced…
Lead a team to ensure medical-device products meet strict quality and regulatory standards, guiding design controls and risk management for hardware and software.
Valencia, CA Senior Manager, Quality Systems Advanced Bionics is seeking a Senior Manager, Quality Systems to lead core global quality system functions within the Quality Assurance organization. This role is…
Owns the end-to-end value engineering pipeline for Sonova's hearing care products in Singapore, driving cost-savings projects across R&D, manufacturing, procurement, quality, and regulatory teams. Core work: BOM analysis, should-cost/Design-to-Cost modelling, and stage-gate project execution using PLM/ERP tools like SAP and Windchill under ISO 13485/FDA/CE compliance.
Job Purpose The Vice President of Quality Assurance and Regulatory Affairs (VP, QA/RA) provides leadership and strategic direction for the Company’s Quality Assurance, Quality Control, and Regulatory Affairs functions.…
En Kelly, nos dedicamos a conectar al talento con el mundo laboral de manera que enriquezca sus vidas y a las empresas con personas talentosas que impulsen la innovación y el crecimiento. Con más de 78 años de…
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans…
OPEN JOB: Senior Manager Regulatory Affairs – Medical Devices LOCATION: Covington, Georgia ***Relocation Assistance Available ***WFH on Fridays BASE SALARY: $150,000 to $165,000 INDUSTRY: Medical Equipment / Devices…
A Career at Clarius Today, as many as 25 million medical professionals globally don't have access to medical imaging, which is proven to improve patient care and reduce healthcare costs. That's why we're on…
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st…
The Role Blackrock Neurotech is seeking a Contract Senior Regulatory Affairs Specialist to provide hands-on regulatory support across our medical device programs. This is a part-time/fractional opportunity, expected to…
Validation Engineer job Overview: Validation engineer is a qualified engineer who manages, inspects, calibrates, evaluates, and modifies the instrumentation, equipment, mechanics, and procedures used to manufacture…
Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people,…
About Femasys Femasys is a pioneering biomedical company focused on advancing women's health by developing and commercializing innovative, accessible solutions for reproductive care. Our product portfolio includes…
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