Remote Quality Systems Specialist - ISO 13485 & Medical Devices
Mira
- Remote job
Mira, a San Francisco-based hormonal health company, seeks a Quality Systems Specialist to maintain the QMS, conduct product compliance reviews, and train staff on SOPs. This role collaborates with R&D to support regulatory compliance and product development, and ensures audits across FDA, Health Canada, TGA, and MDSAP. The position is remote with a 40-hour workweek, offering opportunities to drive quality improvements in a fast-growing femtech startup. #J-18808-Ljbffr Mira
- Solutech is seeking a Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures processes... ...standards and customers' requirements for medical devices. Responsibilities include maintaining calibration...Medical deviceDay shift
$75k - $80k
...Senior Quality Systems Specialist To ensure compliance through the development, implementation... .... Experience within a Medical Device company or ISO 9001/13485 certified company, preferred.... ...Standard office environment and/or remote work. Physical Demands : The...Remote workMedical deviceHourly payWork at office$91.6k - $152.7k
...is seeking to hire a Staff Quality Systems Specialist - Continuous Improvement... ...Wednesday) and the option to work remotely on Thursday and Friday.... ..., including FDA, ISO 13485, MDR, GMP, GDP, and other... ...regulated industry (e.g., medical device, pharmaceutical, biotechnology...Remote workMedical deviceFull timeFor contractors- BISCO is seeking a Quality Systems Manager to lead and maintain the Quality Management System in Schaumburg, IL, ensuring ISO 13485 compliance and regulatory readiness. This hands-on leadership role oversees QA/QC activities, receiving inspection, CAPAs, internal audits...Medical device
- BISCO Dental Products seeks a Quality Systems Manager to maintain the Quality Management System and oversee QA/QC activities in support of ISO 13485 and medical device regulatory requirements. This hands-on leadership role involves managing quality system processes, QA/...Medical device
- Solutech seeks a Quality Systems Specialist to lead the implementation and maintenance of ISO 13485 compliant QMS policies and procedures, ensuring products meet quality standards and customer requirements. You will drive calibration, document control, audits, and CAPA...Medical device
$91.6k - $152.7k
Stryker is hiring a Staff Quality Systems Specialist for our Medical division supporting our... ...requirements for medical devices, drugs, and cosmetics. The... ...) and the option to work remotely on Thursday and Friday .... ...standards, including FDA, ISO 13485, MDR, GMP, GDP, and corporate...Remote workMedical device$144k - $209k
...regulatory expectations.Create a system that can meet audit ready standards... ...experience.8 years of experience in quality engineering or systems architecture for software as a medical device or digital health products.Experience in ISO 13485, ISO 14971, and IEC 62304...Medical deviceShift work- ...We’re seeking an experienced Quality Systems Specialist III to support and continuously improve our... ...Management System (QMS) in a regulated medical device environment. This role will lead QMS... ...investigations Coordinate FDA, ISO 13485, and EU MDR audits and inspections...Medical device
- ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality... ...metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485. #J-18808-Ljbffr ARCHMedical device
- ...Function Independently perform quality-related functions within the... ...and monitor quality systems, including document control,... ...education and experience in medical device manufacturing Proficient in... ...applicable regulations/standards (ISO 13485, FDA, etc.) Ability to read...Medical device
- ...OrthAlign, Inc. , a Smart Technology, growing medical device company, has an immediate opening for a Quality Systems Complaints Specialist. The Quality Systems Complaints Specialist... ...with medical device regulations ISO 13485, 21CFR820 and complaints Strong verbal...Medical deviceLocal areaImmediate start
$75k - $110k
...Supervisor’s Title: Quality Director Exempt or... ...range of benefits (e.g., Medical, Dental, Vision,... ...Function The Quality Systems Specialist II position is... ...roles in the medical device industry. ~ Previous... ...of 21 CFR Part 820, ISO 13485, EU MDR, and other global...Medical deviceFlexible hours- ...Responsibilities Ensures the quality assurance programs and... ...increased oversight. Experience in medical device, pharmaceutical and/or a... ...program. CAPA documentation systems experience (e.g. Trackwise ,... ...as applicable and Part 11), ISO 13485, and Medtronic quality requirements...Medical deviceWorldwide
- ...Position Overview: The Quality Specialist assists in maintaining the Quality Management system of GlobalMed Logistix, a leader in medical device distribution. Daily tasks... ...Federal regulations, ISO standards, and internal... ...for compliance with ISO 13485, FDA regulations, and...Medical deviceWork at office
- ...Position Summary The Quality System Specialist – CAPA is responsible for supporting and maintaining the Quality... ...Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements for medical device operations. This role is primarily focused on...Medical deviceFull timeWork at office
- ...Type: Job Description Position Title: Quality Systems Specialist Reports To: Director of Quality &... ..., our mission is to ensure critical medical devices are always available to support the... ...ensuring the successful implementation of ISO 13485 certified quality management system...Medical deviceDay shift
$40 per hour
...across teams to improve quality systems and compliance, this could... ...The Quality System Specialist will support critical IVDR... ...• Knowledge of GMP and ISO regulations, including ISO 13485, MDSAP, and FDA 820/210... ...requirements • Familiarity with medical device, pharmaceutical, or...Medical deviceHourly payContract workTemporary workWork at officeDay shift$105k
...Overview The Sr. Quality Data & Analytics Specialist is responsible for... ...Regulatory Affairs, Medical Safety, Service, Manufacturing... ...multiple business systems and tools and other... ...science, medical device quality, healthcare... ...is #LI-YA2 #LI-Remote About us With...Remote workMedical deviceTemporary workLocal areaWorldwideFlexible hours$75k - $85k
...Full Time Quality Milwaukee, WI... ...through cutting-edge medical technology. Our... ...great medical device company runs on... ...Management System behind the scenes... ...Systems Specialist, you'll help keep... ...customer audits, ISO audits, and regulatory... ...(QSR/ISO 13485) Why Work...Medical deviceFull timeTemporary workWork at office- Element Science, Inc. is a medical device and digital health company focused on monitoring... ...from hospital to home. We seek a Quality Systems Specialist I to support CAPA, change control, NCRs... ...-market surveillance aligned with ISO 13485 and QMS regulations. #J-18808-...Medical device
$70k - $82k
...VitalPath in Maplewood as a Quality Systems Specialist! VitalPath is a trusted... ...contribute to groundbreaking medical advancements in a... ...within a regulated medical device environment. This role supports... ...and in compliance with FDA, ISO 13485, customer and internal quality...Medical deviceContract workTemporary workLocal areaRelocation packageShift work$120k - $160k
...We are seeking an experienced Senior Quality Systems Specialist to join Synchron’s Quality team.... ...FDA regulated industries (preferably medical devices) and who have experience performing... ...standards including 21 CFR 820 and ISO 13485:2016 Experience administering an electronic...Medical deviceFull timeTemporary workFor contractorsInternshipFlexible hours- Now Hiring: Quality Systems Specialist (Medical Devices) Client Industry: Orthopedic Medical Devices & Musculoskeletal Healthcare Contract Duration - 10... ...device industry . Strong knowledge of: FDA 21 CFR Part 820 ISO 13485 EU MDR ISO 14971 Hands-on experience with QMS...Medical deviceContract workLocal areaImmediate start
$121k - $205k
remote type On-Site locations Northridge, California... ...strong foundation in quality regulations and... ...audit activities. The QMS Specialist partners closely with... ...alignment with quality system requirements and regulatory... .... Experience in the medical device industry with relevant...Remote workMedical deviceFull timeWork at officeLocal areaWorldwideFlexible hours- Quality Systems Specialist II - Training processes and Learning Management System (LMS) Contract Client is a Medical Device company. Implementation of the training process and Learning Management... ...within FDA regulations and ISO-13485 standards Excellent oral and written...Medical deviceContract work
- NeuroOne Medical Technologies Corporation in Eden Prairie, MN, is seeking a Quality Specialist to administer document control and training... ...Quality Management System, and to support other... ...compliance with 21 CFR 820, ISO 13485, and related medical device standards. Help...Medical device
- ...Embedded Systems Engineer Location: Remote Duration: Contract Qualifications: Bachelor... ...a strong background in medical device development. Proficiency... ..., including FDA, ISO, and other industry standards... ...standards (e.g., IEC 62304, ISO 13485) Experience with safety-...Remote workMedical deviceContract work
- ...4827Reference26-01226Remote50% Remote Job Description: We are seeking a Quality Systems Engineer to support and maintain... ...compliance. Experience in medical devices, pharmaceuticals, biotechnology... ...compliance with FDA regulations, ISO 13485, ISO 9001, 21 CFR Part 820/QMSR...Remote workMedical deviceWork at office
- ...Reference26-01044Remote50% Remote Job Description:... ...effective implementation of the Quality Management System (QMS). The position is responsible... ...with applicable medical device regulations and standards,... ...including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as...Remote workMedical deviceWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Quality Systems Specialist - ISO 13485 & Medical Devices. Be the first to apply!
- quality control associate San Francisco, CA
- quality associate San Francisco, CA
- quality system auditor San Francisco, CA
- warehouse quality control associate San Francisco, CA
- quality management specialist San Francisco, CA
- quality improvement specialist San Francisco, CA
- quality assurance auditor San Francisco, CA
- quality auditor San Francisco, CA
- quality specialist San Francisco, CA
- quality systems specialist San Francisco, CA


