Search 11 medical device jobs

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Latest Jobs

Jun 17, 2022  
$165,000 - $200,000 yearly
Safe Health Systems is looking for an experienced Vice President of Quality Assurance and Regulatory Affairs to represent RA and QA on cross-functional project teams. This person will be responsible for implementing the overall regulatory strategy, quality assurance program, quality management system (QMS), and ensuring compliance with regulations and guidelines for medical devices, and affiliated software products.    You will develop and drive a work culture committed to compliance, quality, and customer focus. As a fast-paced startup, we are looking for people who love to learn, can wear multiple hats and are detail-oriented.  We expect people to work independently in their domain while also collaborating effectively with cross-functional teams. Successful execution will lead to significant career growth opportunities. Essential Functions and Accountabilities:  Quality Assurance Key Responsibilities: Fully implement QMS that is compliant with ISO 13485 and FDA...
SAFE Health Systems Remote Full time
Jun 06, 2022  
$70,000 - $90,000 yearly
BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated experienced Quality Engineer team member to contribute to this dynamic project in our Huntington Beach Office CA. The Quality Engineer (QE) will support preparation and review of documentation and inspection required for manufacture and test of the Total Artificial Heart (TAH) system and will work with the team to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820. The QE will work on daily Quality Assurance (QA) activities by supporting creation and review of work instructions, inspection instructions, test protocols, and process Design Change Orders (DCO). The QE will also support inspection activities both internal at BiVCOR and its suppliers. The QE will work closely with the internal engineering staff to the support...
BiVACOR Inc Full time
Jun 06, 2022  
$110,000 - $130,000 yearly
BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated team member to contribute to this dynamic project in our Cerritos Engineering Office. If you have strong organizational, leadership, and interpersonal skills then you should apply to join our energetic and diverse team. The Quality Assurance Manager will work to develop and implement a quality management system in accordance with ISO 13485, 21 CFR 820, and MDR 2017/745. Strong preference will be given to candidates with hands-on, professional experience working with FDA Class III Medical Devices.   RESPONSIBILITIES Lead development and implementation of in-house QMS Lead planning and implementing good manufacturing practice (GMP) and good laboratory practice (GLP) systems Co-leads (with R&D) in implementing Design Control: Conduct risk...
BiVACOR Inc Full time
May 26, 2022  
$90,000 - $120,000 yearly
The Manager of Operations/Quality Affairs, will be responsible for providing operational and quality leadership both strategically and in day-to-day activities. This individual will have sole responsibility for regulatory compliance related activities such as supplier management, change controls, deviations and general QMS maintenance. This individual will also ensure that the QMS and all business activities are in compliance with applicable US and international regulations and will be responsible for planning activities to ensure continued compliance.  This role requires the ability to develop and maintain cooperative working relationships with team members to effectively ensure compliance and timeliness of both (vendor) manufacturing and regulatory activities.   Responsibilities Manage the QMS to include CAPAs, Post-Market Surveillance, Training, Document and Change Control and Record Management. Manage audits (supplier audits as well as third-party, notified body or...
Zetagen Therapeutics Remote (Dallas, TX, USA) Full time
May 13, 2022  
Sprig Oral Health Technologies, Inc. Join our Amazing Team! Sprig Oral Health Technologies, Inc is an innovative and evolving medical device company that is making a positive difference in the field of pediatric dentistry.  Apply online at www.sprigusa.com and go to “careers” link at the bottom of the website. We Offer: Friendly and fun company culture!    Full benefit package including Medical, Dental, Vision, and Life Insurance  Competitive salary offered that aligns with the market for this type of position EAP (Employee Assistance Plan offering FREE mental health services) 2 weeks paid vacation per year 401(k) with company match 9 Paid Holidays Wellness program Tuition Reimbursement, Professional Development and Career Advancement Opportunities Located in Loomis, CA, we offer convenient and free, onsite parking.  Our jobsite is also within easy walking distance to many conveniences including Starbucks, Raley’s, restaurants, and...
Sprig Oral Health Technologies, Inc Loomis, CA, USA Full time
May 02, 2022  
Position Summary and Responsibilities: As a Software Engineer focused on our applications, you will report to Ceevra’s Chief Technology Officer. Your primary job focus will be on building the end-user client (desktop, mobile, and web) and back-end software that clinicians use, and on the automation frameworks for the validation of our machine learning models and other computer vision and graphics-related software. The responsibilities will extend to builds, deployments, data engineering, and the implementation of state-of-the-art machine learning models used to benchmark our software. Local candidates are preferred, although we’ll consider highly qualified remote candidates with at least two years of on-the-job experience. If local, we envision 3 days per week in our SF offices (or more if preferred by the candidate). Responsibilities Develop desktop, mobile, and web-based applications (front-end, back-end, and native apps) Work with the engineering team on...
Ceevra San Francisco, CA, USA Full time
May 02, 2022  
$90,000 - $125,000 yearly
Position Summary: As a Medical Device Software Quality Engineer, your primary job focus will be designing, implementing, and extending the medical device quality processes for Ceevra software that generates and displays 3D models of patient anatomy. Local candidates are preferred, although we’ll consider highly qualified remote candidates. If local, we envision 3 days/week in our SF offices (or more if preferred by the candidate). Responsibilities Drive quality-focused design and development of Ceevra software, including defining appropriate requirements, and creating and executing verification and validation plans and protocols Maintain and extend Ceevra’s Quality Management System Oversee various quality management activities, such as management reviews, internal audits, and external audits Develop quality practices applicable to cutting edge technologies with evolving regulatory guidelines such as Machine Learning Requirements At least three years...
Ceevra San Francisco, CA, USA Full time
May 02, 2022  
What and who we are:   UltraLinq is a SaaS cloud-based medical image solution. We give our clients the ability to read, store, report and archive medical images anytime and from anywhere with an internet connection. We are a mature SaaS company with a startup mentality. Our team solely consists of passionate, motivated problem-solvers dedicated to providing exemplary service to our customers as we improve the healthcare experience for healthcare providers and professionals. We nurture a casual, diverse, and energetic atmosphere with highly supportive co-workers. Who we need:   We are currently seeking a Regulatory and Quality Assurance Specialist to join our team in our New York, NY or Durham, NC office. This is a great position for someone who enjoys working as part of a small team and leading in the maintenance and expansion of regulatory processes. Why you should apply:   If you are looking to make a significant impact in the Quality and Regulatory Assurance space, this...
UltraLinq Healthcare Solutions Remote (Raleigh-Durham, Durham, NC, USA) Full time
Apr 05, 2022  
Join a startup in Westchester County NY. Exciting growth opportunity. We manufacture a class II device with 510K clearance, CE mark under MDD. We are an ISO13485 facility. We're looking for someone who can help us navigate through the MDR process and maintain our QMS. We currently sell in 6 countries besides the US. Salary commensurate with experience - let's discuss.
Retia Medical, LLC Valhalla, NY, USA Full time
Mar 31, 2022  
$100,000 - $140,000 yearly
Desktop Health is leveraging additive manufacturing and advanced materials to personalize patient care. Desktop Health is vertically integrated to develop, manufacture and commercialize applications across a range of healthcare specialties. The company is rapidly focused on leveraging its bio printing capabilities across several key specialties. Position Description: The Quality Assurance Manager will work with an interdisciplinary team to document the design and commercial manufacturing process of novel 3D printed tympanic membrane grafts (PhonoGraft) and other tissue grafts as part of the Desktop Health team. We are a small team located in Boston, MA (parking available), working to improve the lives of people with tympanic membrane perforations and other medical conditions. The candidate will work under the direct supervision of the Vice President of Biomaterials and Innovation, with support from a Manufacturing Engineer, a Mechanical Engineer, a Material Engineer, and...
Desktop Health Boston, MA, USA Full time