9 jobs found

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...

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 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...

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...

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...

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...

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.

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...

Join the team at Charter Medical and use your skills and experience to contribute towards improving the lives of patients globally!   Who We Are: Charter Medical, LLC is a life sciences company located in Winston-Salem, NC, that has supported the development of advanced immunotherapies for over 30 years. The integration of our single-use solutions in FDA-approved immunotherapies has helped improve the lives of patients globally. Our passionate team is committed to designing and developing quality products that support rapid growth in cell and gene therapy, bioprocessing, and blood management.   What We're Looking For: The Health, Safety and Environmental (HSE) Specialist is responsible to plan, coordinate and direct the Health, Safety and Environmental (HSE) Management Systems for a business unit, providing guidance and support in the following areas: safety engineering, safe work practices, risk control, training, management practices, and conformance to HSE...