Medtech QMS Lead - Remote, ISO & FDA
Innolitics
- Remote job
Innolitics is a remote-first medical device consultancy hiring a Quality Assurance Specialist to lead Medtech OS implementations and ongoing quality services. The role focuses on QMS setup, policy creation, and ensuring compliance with ISO 13485 and FDA requirements. Remote work with occasional client travel supports design controls, risk management, and audits. Ideal candidates have 3+ years in medical device QA, FDA inspection experience, and familiarity with Notion or similar eQMS platforms. #J-18808-Ljbffr Innolitics
$80k - $200k
...experienced consultant to lead MedTech Complaints... ...delivery success across QMS implementations.What You... ...DeviceStrong understanding of FDA, EU MDR/IVDR requirements... ...processesKnowledge of ISO 13485 and 14971, FDA 21... ...and/or stock bonus.#LI-Remote#LI-MidSeniorVeeva’s headquarters...Remote workWork at officeLocal areaWork from home3 days per week$125k - $201.25k
...Innovative Medicine and MedTech, we are uniquely positioned... ...Job Posting Locations: Remote (US), Santa Clara,... ...Regulatory Affairs Program Lead to support our OTTAVA robotics... ..., writing and filing of FDA submissions (e.g., Q-... ...IEC 60601 series and ISO 10993-1. Strong knowledge...Remote workLocal areaImmediate startFlexible hours- ...a subsidiary of Munich Re, seeks a qualified auditor to perform ISO 19443 customer audits across the United States. The role requires... ...engineering or related fields, nuclear industry experience with QMS auditing, and proven writing and communication skills to engage with...Remote job
- ...Job Title: Construction QMS Lead Location: Richmond, Virginia Contract: Initial 12 months Working arrangement: Remote or hybrid initially, transitioning to fully on site once construction begins Compensation: Competitive W2 hourly rate, with expenses covered...Remote workHourly payContract work
- Carhartt, Inc. is seeking a Quality Management System Lead in a remote-capable role based from Dearborn, MI. The role will develop and implement a scalable QMS framework spanning global sourcing, including finished goods vendors and raw material suppliers, and lead the...Remote job
- ...looking for a Quality Assurance professional to support day-to-day QMS activities and execute the safety program across management and... ...and external audits, change control, and policy upkeep to maintain ISO 9001:2015 compliance. The position emphasizes 5S standards,...
- ...Veeva Systems, Inc. is seeking a Senior Product Manager for MedTech to lead the MedTech-specific vision within the Vault CRM ecosystem. You will collaborate with the broader PM team to evolve core platform capabilities for Medical Device and Diagnostic companies and...Remote job
$109k - $174.8k
...expertise in Innovative Medicine and MedTech, we are uniquely positioned to... ..., United States of America, Remote (US) Job Description: About... ...Regulatory Affairs Program Lead to support our Wound Closure... ..., writing and filing of FDA submissions (e.g., Q-submissions...Remote workFull timeLocal areaImmediate start- DQS Inc. is seeking Contract Lead Auditors to perform ISO 9001, ISO 14001, ISO 45001 and related standards audits across the United States. This... ...travel and the ability to audit at client locations, often remotely from home when not traveling. The ideal candidate has IRCA...Remote jobContract work
- Job-ID32400670Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and inspection readiness activities across the business.... ...programs. · Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations. ·...Remote work
- IMSM (International Management Systems Marketing) seeks experienced ISO 13485 Lead Auditors to join its professional network on a self-employed basis. The role is UK remote with occasional on-site client visits, offering flexible contracting and a steady pipeline of assignments...Remote jobContract workSelf employmentFlexible hours
- ...Science, AI, and Agentic projects/programs Lead multidisciplinary workshops and design... ...roles in the Healthcare, Pharmaceutical, MedTech/BioTech space 5+ years in a leadership role... ...Experience navigating regulatory processes, ISO/IEC Standards, HIPAA, EU AI Act, GxP, etc....Remote work
$140 per hour
...Teamcenter PLM Solution Architect & Discovery Lead Location: Remote within the United States, with... ..., and executives. ~ Medical device or MedTech experience preferred, particularly in regulated product development and QMS/PLM processes. ~ Authorized to work in...Remote workHourly payLong term contractFull timePart timeLocal area- ...System Guidelines, and the Client's Quality Program Plan; submit for Client review and approval. Lead and maintain an ISO 9001-aligned Quality Management System (QMS) for the program. Serve as the primary authority for QA/QC governance across the team and all program...Remote workContract workFor contractors
- ...Senior Regulatory Affairs Program Lead position supporting wound closure and healing medical... .... Based in Raritan, New Jersey with remote work options available. Responsibilities... ...and healing portfolio Prepare and submit FDA and EU regulatory submissions, including 5...Remote work
- ...Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding execution... ...on cross-functional teams. Onsite 3 days per week with some remote work, the position collaborates with regulatory agencies to align...Remote work3 days per week
$120k - $150k
...CooperSurgicalCooperSurgical is a leading fertility and women’s... ...activities, ensures regulatory and QMS compliance, and drives... ...Abilities:Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.... ...supplier audit programs (onsite, remote, desktop).Ensure effective...Remote work$120k - $200k
A leading life sciences technology company is looking for a Senior Product Manager to define and deliver the MedTech strategy. Ideal candidates will have significant experience in MedTech product management or commercial operations. Responsibilities include influencing...Remote jobFlexible hours$163k - $180k
...(SDLC) Security and Compliance Lead defines, refines processes, and... ...Organization for Standardization (ISO) 9001, ISO 27001, CRA... ...full-time role with hybrid and remote opportunities available. Responsibilities... ...2443, ISO 27001) practices and QMS documentation Maintaining...Remote workFull timeH1bWork visa$90k - $95k
...Job Description Job Description ISO/NSF Quality Systems & Laboratory Lead Location: Beaumont, TX | Reports to: Operations Manager | Compensation... ...system oversight; training toward Chemtrade ISO auditor. QMS leadership: registrar/auditor communications, CAPA...- Everforth Apex in Bertram, TX is seeking a Quality Auditor to lead internal audits under AS9100, draft and update SOPs, and drive proactive... ...U.S. citizenship for ITAR/EAR compliance is required. Travel to remote locations may be required in a fast-paced startup environment....Remote work
- Own and improve QMS for simulation products, programs, and services. Conduct risk-based audits and maintain ISO 9001:2015 certification. Customer and Supplier Quality: Serve as primary... ...down and are verified before acceptance. Lead CAPA activities and root-cause analysis...Remote jobFor subcontractor
- ...Louis site. You will provide strategic leadership for QA and regulatory compliance, maintain the ISO 13485 QMS, and align with global quality strategy while overseeing FDA and USDA registrations. As a key member of Global Quality, you will partner with Manufacturing,...
- ...Quality Management Systems Supervisor to oversee the development, implementation, and maintenance of the QMS, ensuring ISO 9001, ISO 13485, and AS9100 compliance. You will lead internal and external audits, drive CAPA, manage eQMS and document control, and mentor cross‑...
- ...products, driving sustained growth and leadership in cardiovascular MedTech. The role reports to the VP of Global Sales and Marketing,... ...and shapes pricing, campaigns, and product launches. This is a remote role across the U.S. #J-18808-Ljbffr Johnson & Johnson MedTech...Remote job
- ...flexible workspace and “Top 100 Company for Remote Jobs” 6 years in a row. Great Place to... ...Enablement & Governance - Security & Controls Lead enables secure, responsible, and scalable... ...NIST AI RMF/CSF, NYDFS AI Cybersecurity, ISO/IEC 42001)Contributing to the broader AI policy...Remote workWork at officeLocal areaWork from homeWorldwideFlexible hours
- ...supporting, maintaining, and improving the company’s Quality Management System (QMS) to ensure compliance with company standards, customer requirements, and applicable regulatory standards, including ISO 9001:2015. This role collaborates cross-functionally with operations,...Contract workWork at officeLocal area
- Overview Quality Management System Supervisor / QMS Supervisor — Riverside County, CA • On-... ...Quality Management System Supervisor to lead site-wide QMS strategy, from audits to... ...review. You\'ll drive compliance with FDA and ISO standards while partnering with the management...
$157.43k - $208.43k
...contract award**SOSi is seeking a Cybersecurity Lead to join our team in Fort Shafter, Hawaii.... ...regulatory standards such as GDPR, HIPAA, ISO 27001, and NIST.Experience with securing... ...an office environment, with occasional remote work options.Occasional travel and the ability...Remote workContract workCasual workWork at office$147.6k - $164k
...and EVM Team. The responsible person will lead and supervise a team of Project Controls Analysts... ...Management Certification (RMP and ISO 31000) is highly desirableSix Sigma is highly... ...guidelines apply to roles approved for remote work and are subject to change, based on managerial...Remote workFull timeContract workH1bWork at officeShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medtech QMS Lead - Remote, ISO & FDA. Be the first to apply!
- software engineering manager remote New York, NY
- remote recruitment consultant New York, NY
- remote data manager New York, NY
- business intelligence analyst remote New York, NY
- benefits specialist remote New York, NY
- junior angular developer remote New York, NY
- remote video game New York, NY
- remote typing work New York, NY
- remote construction estimator New York, NY
- remote fashion New York, NY






