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
- ...support a growing hormonal health company, the remote Quality Systems Specialist will maintain the Quality Management System... ...or Regulatory Compliance within the IVD or Medical Device industry In-depth understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory...Remote workMedical deviceFull time
$75k - $80k
...Senior Quality Systems Specialist Quality Department Reports to Sr. Manager Quality... ...experience. 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 payFull timeWork at office- Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role... ...living in the United States. You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with clients...Remote jobMedical deviceNight shift
- ...experienced Independent Contract Quality Management System (QMS) Auditor to support... ...: North America – Remote with onsite travel as... ...regulated industries, including medical devices, biotechnology,... ...QMS standards, including: ISO 9001, ISO 13485, ISO 17025, MDSAP, 21 CFR...Remote workMedical deviceContract workFor contractorsWork at office
$50k - $60k
...Quality Systems Associate Support the maintenance and day-to-day administration... ...industry experience. Experience in a medical device company or other ISO 9001/13485-regulated environment is... ...Standard office environment and/or remote work. Physical Demands : The...Remote workMedical deviceHourly payWork at office- 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
- Jabil is seeking a quality engineering leader to champion the development, implementation... ...of the quality management system. You will specialize in ISO 13485 and CFR 820.30, define document... ...regulatory compliance across medical device programs. You will provide strong...Medical deviceWorldwide
- ...Job title : Principal Quality Systems Specialist Client : Medical Device Manufacturing company Duration :... ...medical device regulations, including FDA QMSR, ISO 13485, and European Medical Device Regulation (EU...Medical deviceContract workShift work
- ...Job Description Job Description Quality Systems Specialist (Mid-Level) Job Summary The... ...certification assessments (e.g., ISO 9001, ISO 13485, AS9100, as applicable). Track... ...Experience in a regulated manufacturing, medical device, aerospace, or pharmaceutical...Medical deviceWork at office
$30 - $38 per hour
...Job Description Job Description QUALITY SYSTEMS & TRAINING SPECIALIST Santa Rosa, CA | $30–$38/hr... ...principles. ~ Strong knowledge of ISO 13485 and 21 CFR Part 820. ~ Strong... ...multiple priorities and projects. ~ Medical device or pharmaceutical experience...Medical 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
- 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
- ...Quality Systems Specialist Integrated Resources, Inc is a premier staffing firm recognized as one... ...or auditing experience · Previous medical device or other regulated industry... ...Quality System Regulation (21CFR820), ISO 13485:2003, and CFR Parts 210 and 211....Medical device
- ...pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory... ...standing up their first quality systems. Quality Engineer Medical Device (CAPA, ISO 13485, Risk Management) JOB...Medical deviceHourly pay
- ...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
$40 - $45 per hour
...Job Overview – Product Quality Specialist (Temporary) Compensation: $40 – $45/hour (... ...regulatory reporting, and quality system compliance within a medical device environment. This role will analyze... ...experience with knowledge of ISO 13485, ISO 14971, FDA regulations, complaint...Medical deviceTemporary workWork at officeMonday to Friday- ...DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialist to work in a dynamic Medical Device Research and Development environment.... ...Understanding and working knowledge of ISO 13485 and Quality System regulation is required...Medical deviceContract workWork at office
- ...Staff Quality SpecialistThe Staff Quality Specialist will evaluate and harmonize existing Quality Management System (QMS) procedures, work instructions,... ...related function within the medical device industry.Experience... ....Working knowledge of ISO 13485, FDA QSR/QMSR, EU MDR...Medical deviceWork at office
- ...The Quality Systems Specialist III will play a pivotal role in maintaining and enhancing our QMS to ensure compliance with ISO 13485, FDA, EU MDR regulations, and other applicable international... ...have a strong background in medical device quality systems and regulatory...Medical device
$94.7k - $157k
...monitoring of conformance to established quality systems processes and standards for... ...Management Review Process, Quality Planning, ISO Audits, and Regulatory Inspections.... ...0/211 and Part 11).Knowledge of ISO 13485 and Canadian Medical Device Regulations (CMDR).Prior experience...Medical deviceFull timeWork experience placementWork at officeLocal area$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$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$87k - $100k
...Quality Systems SpecialistElement Science, Inc. is a medical device and digital health company redefining how patients with heart... ...looking for a Quality Systems Specialist II with passion for creating... ...audits, ensuring compliance with ISO 13485, QMSR, and other applicable...Medical deviceTemporary workLocal areaVisa sponsorshipWork visaRelocation packageFlexible hours- ...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
$74.35k - $102.23k
...Quality Systems & Training Specialist (Finance) Join us in pioneering breakthroughs in healthcare. For everyone... ...operate within a highly regulated medical device environment. In this role, you... ...requirements, including ISO 13485, MDSAP, MDD, and MDR. Experience...Medical deviceTemporary workWork at officeLocal area$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$135.5k - $216.8k
...the largest global medical technology companies... ..., external (FDA, ISO, etc.) and customer... ...site coordinator for Quality Notifications (NCs... ...Site and WW Quality Systems. Supports... ...8 years of medical device, biologic, pharmaceutical... ...including 21CFR820, ISO 13485, MDD/MDR, MDSAP...Medical deviceHourly payDaily paidTemporary workFlexible hoursShift work- ...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
- 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
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