Medical Device QMS & BSI Audit Readiness Lead
VOLTO Consulting
VOLTO Consulting is looking for a qualified candidate to oversee BSI readiness audits in Austin, Texas. You will be responsible for planning, scoping, and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745. The ideal applicant should possess a Bachelor's degree in a relevant field and at least 8 years of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to provide constructive feedback are a must. #J-18808-Ljbffr VOLTO Consulting
- ...implementation of the Quality Management System (QMS). The position is responsible for... ...(QMS) in compliance with applicable medical device regulations and standards, including FDA... ...solutions to save time and money. Synkriom leads the industry with experience...Medical deviceWork at officeLocal area
- Key Responsibilities Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745. Conduct rigorous onsite...Medical deviceImmediate start
$60k - $75k
Job Title Sales Associate, Game Ready - United States Location Territory: USA (prefer candidates near major metro-area with airport... ...experience working with Game Ready products. Healthcare, medical device, or sports medicine experience. Experience with capital medical...Medical deviceNight shift$100k - $125k
...Senseye is developing AI-enabled software medical devices to help make mental health assessment... ...and product teams to build practical, audit-ready quality processes for SaMD development.... ...lifecycle thinking. Help define pragmatic QMS processes for a fast-moving regulated...Medical deviceTemporary workFlexible hours- Senseye, Inc. in Austin, TX is searching for a quality engineer to oversee medical-device design quality and software lifecycle documentation. The role demands extensive expertise in design controls and hands-on software experience. You will engage cross-functionally,...Medical device
- ...seeking a Quality Management System Specialist to ensure compliance with medical device regulations. This role involves supporting the development and implementation of the Quality Management System (QMS) and requires extensive knowledge of FDA regulations, ISO standards,...Medical device
- ...Territory Manager Peripheral Nerve Stimulation (PNS) Are you ready to work for a more active world? At Bioventus, our business... ...quota) preferably in the biotech, life science, pharmaceutical, medical device or related industry strong business to business selling experience...Medical device
- ...for the Automotive, Consumer Goods, and Medical Device Industry. The company is in an expansion... ...extensive expertise in Tool & Die, adeptness in leading cross-functional teams, and a sharp... ...of parts Provide dies that are ready for production Repair or manufacture...Medical deviceRelocation package
- ...s Quality Management System (QMS). This role provides strategic... ...targeted outcomes. You will lead the formation of workstreams... ...partners to architect scalable, audit-ready frameworks, including... .../ supply chain monitoring or medical device industries Experience with...Medical deviceFlexible hours
- ...level quality for Class II robotic medical devices. This role ensures compliance... ...alignment across design and production readiness. Participate in DFX (Design for... ...the Quality Management System (QMS). Support internal and external audits, CAPA investigations, and...Medical device
- ...seeking an Assembly Technician in Austin, TX, to join a startup manufacturing team. The role involves assembling and inspecting medical device components using basic hand tools in a climate-controlled environment. You will contribute to a growing function, taking on...Medical device
$71k - $145.22k
The Texas State Auditor's Office is hiring an Audit Project Manager responsible for managing complex audit projects and ensuring compliance with state laws. The role includes leading audit teams and coordinating resources to complete audits efficiently within deadlines...Work at office$97k - $121k
...seeking a highly skilled Software as Medical Device (SaMD) Quality Engineer with... ...to ensure compliance with Senseye QMS and regulatory requirements. Ensure... ...root cause analysis techniques. Lead or support internal and external audits (e.g., FDA, Notified Bodies, ISO registrars...Medical deviceTemporary workFlexible hours- ...Are you a knowledgeable and driven sales professional, ready to expand your skills into the medical devices field? Our client is searching for a charismatic person with great communication skills to join their team in selling cutting-edge surgical products. A bit about...Medical devicePermanent employmentTemporary workWork from home
- ...strategic plans to foster business growth, leading high-level negotiations, and ensuring... ...including biotech, pharmaceuticals, or medical devices, is preferred. The role also involves managing... ...a dynamic and innovative professional, ready to make a significant impact within a...Medical device
$71k - $119k
Neuralink is looking for a Regulatory Engineer in Austin, Texas, to join their Regulatory Team. This role involves managing regulatory affairs and ensuring compliance during product development and post-market phases. Candidates should have a Bachelor’s degree in engineering...Medical deviceFull time- ...This role is primarily focused on execution, compliance support, audit readiness, and day‑to‑day quality operations across GoodPop's... ...contract manufacturers Experience with quality management systems (QMS) and basic data analytics tools Familiarity with frozen food,...Contract workLocal areaRemote work
- ...conservative sector. We are now ready to scale our go‑to‑... ...processes and lead efforts to improve them... ...certification readiness and audit performance (e.g., ISO,... ...industrial equipment, medical devices, or similar). Hands‑on... ...quality management systems (QMS) and regulatory or...Medical deviceContract workTemporary workRelocation packageFlexible hours
- A medical device company located in Austin, Texas is seeking a Quality Management System specialist. This role involves ensuring compliance with medical device regulations and standards, supporting the implementation of Quality Management Systems, and collaborating with...Medical device
- A leading medical device company in Austin is seeking an experienced Electrical Hardware Engineer to support R&D and manufacturing of innovative cancer treatment technologies. The ideal candidate will have a background in electrical engineering with over 7 years of experience...Medical deviceContract work
- ...staffing agency is seeking a Quality Systems Specialist in Austin, Texas, to enhance the Quality Management System (QMS) for a leading orthopedic medical device company. Responsibilities include supporting QMS development, conducting compliance assessments, and partnering...Medical deviceContract work
- A leading technology firm is seeking a Senior Electrical Design Engineer to support R&D and manufacturing in Austin. Candidates should... ...product quality. This on-site position offers a collaborative environment focused on medical devices. #J-18808-Ljbffr Cube Hub Inc.Medical device
- ...improvement. Ideal candidates have a degree in Engineering or a related field and experience in regulated manufacturing environments. The position offers generous benefits including 5 weeks paid time off and comprehensive medical coverage. #J-18808-Ljbffr Artivion, Inc.Medical device
$97k - $121k
Senseye, based in Austin, TX, is looking for a qualified Software as Medical Device (SaMD) Quality Engineer to oversee AI-enabled products. This role requires substantial experience in medical device quality systems and compliance with regulatory standards. The position...Medical deviceFlexible hours$105k - $175.5k
Neuralink in Austin, TX seeks an Electrical Engineer for the Surgery & Robotics Hardware Team. This role focuses on designing and overseeing custom electronics systems that support cutting-edge healthcare technologies. The ideal candidate should have a Bachelor's in Electrical...Medical device- A leading medical equipment manufacturer is seeking a Senior Manufacturing Engineer to support site transfers and product launches. This role requires a minimum of 4 years of experience in medical device manufacturing, along with strong knowledge of process validation and...Medical deviceContract work
- ...seeking a Senior Quality Engineer II to provide design assurance and ensure compliance with FDA and ISO standards for robotic medical devices. The role involves collaborating with various engineering teams and supporting product risk management to enhance patient outcomes...Medical device
- A technology firm in Austin seeks a Senior Electrical Engineer for a contract role focused on medical device manufacturing. The ideal candidate will have over 7 years of experience, a strong electrical design background, and skills in test engineering. Responsibilities...Medical deviceContract workFlexible hours
- DiaSorin is seeking a Manufacturing Engineer, Level II, located in Austin, Texas. This role involves designing and implementing automated control systems for enhancing manufacturing efficiency and reliability. Ideal candidates will have a Bachelor's degree in engineering...Medical device
- Ready to Redefine Mental Healthcare? Join Serenity. If you're a psychiatrist... ...treat — if you're ready to lead, innovate, and elevate care —... ...Provide meaningful care with medication, TMS, and ketamine therapy—all... ...Are: Using advanced medical devices recently released to market,...Medical deviceFlexible hours
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