Overview
QA/QC Specialist (Pharmaceuticals, Medical Devices, SaMD) | USA (Remote) Jobs in United States at xCARE
Title: QA/QC Specialist (Pharmaceuticals, Medical Devices, SaMD) | USA (Remote)
Company: xCARE
Location: United States
[About xCARE]
xCARE Inc. operates a global platform for experts specializing in the pharmaceutical and medical device industries. Our network of over 700 highly skilled experts is dedicated to driving innovation by providing hands-on support for R&D and commercialization, accelerating efficient pathways for development worldwide.
Today, while many groundbreaking ideas emerge from academia and startups, only a small fraction reaches the market, as the difficulty of single-handedly assembling human resources from across every necessary stage of the development process poses a significant hurdle for many startups. However, this bottleneck hinders medical innovation. How do we tackle this issue? At xCARE, we approach this challenge by cultivating a system where “the right expertise is accessible exactly when it’s needed.” Through fostering a dynamic network of experts who can contribute on a project-to-project basis, we empower startups to overcome resource limitations while providing seasoned professionals with new opportunities to make a meaningful impact.
Join Us Today as a Registered Expert
Currently, we are seeking experienced pharmaceutical/medical devices development specialists to join our expert network. This opportunity is open to freelancers, retired experts, and professionals seeking side projects. Even if you are not currently able to take on side work, we welcome those considering a future career change to register as well. If you resonate with our mission to drive medical innovation, join us today as a registered expert with xCARE.
https://www.xcare-medical.com
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[Area of Expertise]
QA/QC (Pharmaceuticals, Medical Devices, SaMD) (USA)
[Main Responsibilities]
Ensure regulatory compliance, including preparation of submission documents (e.g., INDs, NDAs, 510(k)s, PMAs, or CE marking).
Develop and implement quality management systems (QMS) for GMP (pharmaceuticals) and ISO 13485 (medical devices).
Review regulatory documents, labels, and technical files to meet required standards.
Support audits and inspections, ensuring continuous compliance with regulatory and quality requirements.
Collaborate with internal teams and external stakeholders to ensure timely market access and approvals.
[Qualifications]
– Required: At least 5-10 years of experience in QA/QC.
– Strong knowledge of relevant FDA regulations, ISO 13485, and other relevant industry standards.
– Experience with audits, risk management, CAPA.
[Compensation/Work Style]
Compensation: Approx. $150 – 300 /hr (varies depending on project details).
Work Style: Remote. Work style and hours vary depending on client projects. Most opportunities typically last for a few months, and schedules are flexible, with adjustments made in consultation with clients.
Travel: Some projects may require business travel, depending on the client’s project details. (Travel expenses will be reimbursed separately.)
**Participation will be under a service agreement with xCARE.
[Registration Process]
①Apply via LinkedIn
↓(Screening)
②Complete Registration Form sent via LinkedIn
↓
(③ Casual Interview with a Recruiter (if asked) )
↓
④xCARE Platform Registration Completed
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Please note that registration does not guarantee immediate job offers. Opportunities will be provided based on availability and your expertise’s alignment with our client’s needs.
For more details, please check out our other job listings, refer to our website: https://www.xcare-medical.com or feel free to reach out through this post.
