7 remote jobs

About Scanwell Scanwell Health is an app that turns your smartphone into a clinical lab. By pairing traditional lab tests with computer vision technology, we make it possible to test from the safety of home and get instant results without having to send samples back to a lab. Our technology helps healthcare organizations provide better virtual care and improves access to diagnostics in low- and middle-income countries. Most recently, we’ve partnered with global medical technology company BD to power at-home testing for COVID-19. Scanwell is looking for a Quality Compliance Specialist to join our Regulatory team. The Scanwell Quality Compliance Specialist will ensure compliance with applicable QA systems (FDA/ISO/HIPAA ). They will report to the Regulatory team but work closely day-to-day with management and individuals of other groups (Engineering, Design, etc.) to ensure appropriate compliance. About the job As a Quality Compliance Specialist, you’ll be responsible...

The Senior Systems Engineer will be working with the product, platform, and software engineering team to provide design contr ol and software/systems development guidance. As a Senior Systems Engineer, you'll apply cutting - edge techniques and technologies, build great products, develop reusable platforms and grow great teams. You'll be a key technology and process leader at Orth ogonal and intimately involved in almost every aspect of a solution lifecycle from project inception, engineering design, implementation to maintenance and continuous improvement. These solutions include cloud - based applications, mobile, web, and web serv ices for the life science industry, and are used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment. Important aspect of the role: You're comfortable in a client facing role, being a technology leader as well as a team leader. What will...

This is a part time job for 10-20 hrs/week for 6-8 months with a potential to become full time. The applicant will be asked to help complete Kaya17's eQMS system and assist with completion of the DHF.  The ideal applicant will have had at least one year's experience working with QMS systems in a medical device (Diagnostics) company and will have a Bachelor's degree in a science or engineering subject.  The candidate will be asked to be on site at least one day in the week and will be an independently motivated individual with drive to accomplish the mission.  The position starts immediately.  The candidate should write a short cover letter along with their resume. 

CenterMed, Inc. is a medical device startup focusing on developing patient-matched maxillofacial surgical plans and accessories. We are looking for a Quality Engineer to join our CenterMed team! In this role, you will be working with other department partners to deliver safe and effective medical device designs for manufacturing, compliant with CenterMed policies and procedures. You will provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO13485, ISO 14971, 21 CFR Part 820. Job Responsibilities: Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained Executes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis Supports regulatory and...

Job description CenterMed, Inc. is a medical device startup based in the exciting bay area. CenterMed, Inc is determined and focused on developing patient-matched maxillofacial surgical accessories. We are looking for a R&D Engineer to join our CenterMed team.   ESSENTIAL DUTIES and RESPONSIBILITIES: ·      Design, develop and optimize patient-matched products ·      Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications ·      Develop test strategy based on design requirements derived from voice of customer, and execute protocol, testing, data analysis, and reports required for regulatory submissions ·      Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations ·      Create and update design control documents, including updating risk analysis...

Compliance Solutions is looking for a Senior Quality/Regulatory Consultant to help support all activities within the organisation. The role is homebased in the UK, with travel to clients sites when required. Key areas of responsibility:  Set up/Maintenance of technical documentation & design dossiers Undertaking US FDA 510(k)s, PMAs (Premarket Approvals), IDEs (Investigational Device Exemptions), Pre-Submissions and Designations Submission Regulatory submissions – global markets Support for the development of the company's regulatory planning, incorporating strategies for the product range in accordance with global requirements. Administrate regulatory dossiers to support product license applications, import license and product license maintenance for Regulatory Authorities Quality Management Support Solving regulatory questions on classification, technical files, device master records (DMRs). Device history records (DHRs). Design history files (DHFs), process...

Why TEAM? We are hiring! TEAM is seeking a Business Development Manager  to join our group in  Morristown, TN. Your main objective is to drive revenue growth for the organization through prospecting and winning new business as well as growing revenue organically with existing customer base. Responsibilities include developing strong relationships with prospects/customers, working with internal team to develop quotations, presenting quotes to customers, and negotiating to final sales. You "own" the customer and creates forecasts, communicates pricing initiatives and are involved with contractual reviews. About Us One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers.  With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer’s business. Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding...