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Latest Jobs

Jun 17, 2021
$3,000 - $3,300 monthly
Quality Assurance Manager* *all gender We are SMILE. A technology-based, dynamic company in Vienna. With our colorful team of lateral thinkers, creatives and heroes, we are initiating a new era by developing an outstanding consumer product. Our approach is moving, innovative, a little crazy and always 100% goal oriented. Your tasks: As a Quality Assurance Manager… … you are passionate about the implementation of quality measures in accordance with ISO 13485 and the medical devices regulation, and you are also involved in quality projects. ... you show initiatives and set activities to improve the quality processes regarding internal and external quality requirements. ... are the maintenance of a document control system as well as keeping quality records and performing internal quality controls your passion. … you are passionate about supporting the preparation and participation of internal and external audits. … you stand for the maintenance and further...
Smile Projektentwicklungs GmbH Stumpergasse 14, Vienna, Austria Full time
Jun 16, 2021
Job Purpose and Summary Centerline Biomedical, Inc., a medical device start-up with high growth potential, seeks to hire a Senior Quality Engineer. The Senior Quality Engineer plays a key role in a fast paced, rapidly growing medical device start-up company.  The Senior Quality Engineer is an Exempt/Full-Time role responsible for developing, maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 14971, ISO 13485, MDSAP and FDA 21 CFR Part 820. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. The Senior Quality Engineer will also plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of Centerline’s quality systems. Centerline Biomedical, a...
Centerline Biomedical Cleveland, OH, USA Full time
Jun 14, 2021
Our client is a top 15 global medical device company with 50 years of history bring successful products to patient populations.  We are supporting their Neurotechnology Division for a   Senior Program Manager  to lead a cross-divisional NPD team focused on the development of an integrated and intelligent ecosystem for a broad range of products including Neuro, Spine, and ENT medical devices. The Right Talent: BS in Engineering or related degree/MBA or MS preferred 10+ years of medical device experience managing complex NPD programs with multiple projects involved Experience with program management tools to plan, track and drive programs/projects Experience with systems integration of multiple platforms Strong problem-solving, cross-functional and analytical skills needed Computer Systems background in NPD preferred  PMP or Scrum Master certification preferred Experience with Agile Product Development  Relocation Assistance Available and H1-B Transfers are a...
Shurig Solutions Michigan, USA Full time
Jun 14, 2021
Our client is a world leader in medical technology; offering innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery for over 35 years. They are looking for a  Design Quality Assurance Engineer II  to join their team. This position will support NPI/NPD working cross-functionally with NPD, manufacturing, and RA.  This opportunity can be located near Billerica or Mansfield, MA.  SSI helped 3 people join this team before the pandemic and they are growing agin. The Right Talent: BS or MS in Engineering or relevant degree/experience  2-5 years of medical device quality experience preferred Great opportunity for someone with the right experience to get in the medical device industry Relevant experience in more than one area: design quality, risk management files, design controls, reliability, dFMEA, pFMEA, TMV, etc. Experience with medical device software product development/complex electromechanical systems preferred...
Shurig Solutions Mansfield, MA, USA Full time
Jun 14, 2021
Our client is a top 20 global IVD Medical device company with over 30 years of history bringing solutions to the diagnostic, hospital, and laboratory industries.  This division develops IVD solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings and we are supporting our partner for a new  Quality Assurance Specialist  that will be responsible for creating, revising, and managing product labels for all product labeling electronic files.   The Right Talent: BS in a Molecular Biology, Engineering or relevant Scientific Discipline  2+ years of medical device, IVD, or Biotech QA experience Experience with Desktop Publishing or similar programs well-spoken; works well in a cross-functional environment   Relocation assistance available
Shurig Solutions Ann Arbor, MI, USA Full time
Jun 14, 2021
Our client is a world leader in medical technology; offering innovative solutions in surgical instrumentation, neurosurgery, reconstructive, and general surgery for over 30 years. We are supporting them for a  Sr Product Manager  to join their team and support their Dural Access & Repair business.  The right person will have an entrepreneurial spirit, great communication skills, have experience with physicians/surgeons with experience in a hospital setting.     We have helped 33 people join this client in the past 3 years including 3 on the marketing team. The Right Talent: BS in Business, Marketing, Mechanical Engineering, Biology or related field MS or MBA preferred/strong business acumen and analytics experience 5+ years of experience with commercial marketing experience with medical devices or combination products Experience with digital marketing, remote training preferred Experience with market research, investigation, marketing strategy, and leading...
Shurig Solutions New Jersey, USA Full time
Jun 11, 2021
Our client is a world leader in medical technology; offering innovative solutions in surgical instrumentation, neurosurgery, reconstructive, and general surgery for over 30 years. We are supporting them for a  Sr Product Manager  to join their team and support their industry-leading Ultrasonic Tissue Ablation business.  The right person will have an entrepreneurial spirit, great communication skills, have experience with physicians/surgeons with experience in a hospital setting.   We have helped 33 people join this client in the past 3 years including 3 on the marketing team The Right Talent: BS in Business, Marketing, Mechanical Engineering, Biology or related field MS or MBA preferred/strong business acumen and analytics experience 5+ years of experience with commercial marketing experience with medical devices or combination products Experience with digital marketing, remote training preferred Experience with market research, investigation, marketing strategy,...
Shurig Solutions New Jersey, USA Full time
Jun 10, 2021
JOB DESCRIPTION The Quality Specialist / Quality Engineer will provide support to the Regulatory Team and Clients on quality deliverables and client interactions for assigned projects. The Quality Associate / Quality Engineer is responsible for supporting our clients in the development and implementation of their Quality Management Systems, drafting documentation per applicable regulations and standards, and developing strategies to help client achieve compliance under rapid timelines. This is NOT a document job but will involve critical thinking and strategy. This role will report into the Quality Assurance and Regulatory Affairs Manager. A DAY IN THE LIFE · Identify and interpret regulations, guidelines, literature, and any other pertinent information issued by applicable regulatory agencies and other regulatory or standard organizations · Interpret and identify key concepts in client documentation · Lead, author, and maintain quality documentation (procedures,...
Proxima Clinical Research Full time
Jun 10, 2021
JOB DESCRIPTION The Regulatory Affairs Manager will provide support to the Regulatory Team and Clients on regulatory deliverables and client interactions for projects. The Regulatory Affairs Manager is responsible for assisting clients with development of product development planning and implementation, providing regulatory advice, preparing FDA submissions, maintaining Regulatory Chronological Files and other duties relating to Proxima support of client regulatory needs.This is NOT a document job but will involve critical thinking and strategy. This role will report into the Director of Regulatory Affairs. A DAY IN THE LIFE ·  Meet with early stage companies to provide high level regulatory consulting early on ·  Assist with development of project/study budgets, proposals, and letters of support for leads brought in through early stage consulting and regulatory help desk efforts · Provide regulatory strategic planning for investigational products, analyze...
Proxima Clinical Research Full time
Jun 09, 2021
$100,000 - $140,000 yearly
The Principal Preclinical Scientist will serve as a key scientific contributor for the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. The individual will independently design, execute, analyze and interpret preclinical studies to understand the safety and efficacy of product concepts. The individual will work closely with cross functional groups to meet project timelines. The Principal Preclinical Scientist reports to the Director of Preclinical Research. Responsibilities Serve as core team member on project teams. Serves as a subject matter expert to support preclinical due diligence Provide preclinical scientific input on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle. Responsible for partnering and contributing to Preclinical Strategy, and for the project per...
Cresilon, Inc. 122 18th Street, Brooklyn, NY, USA Full time