Remote FDA Consultant - ISO 13485 & ISO 22716 Expert
IMSM
- Remote job
IMSM is seeking a Freelance FDA Consultant with expertise in ISO 13485 and ISO 22716. This role involves providing strategic guidance on FDA regulatory requirements, supporting submissions and inspections, and developing Quality Management Systems (QMS). Ideal candidates should have proven experience in regulatory affairs, strong knowledge of FDA regulations, and excellent communication skills. The position allows remote work with occasional on-site client visits, offering flexibility within a respected consultancy. #J-18808-Ljbffr IMSM
- Overview Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience) USA Remote (with occasional on-site client visits) Contract / Self-Employed Basis About IMSM... ...growingnetwork of 85 employees and more than 350 expert contractors enables us to deliver high-quality, results...Remote workContract workFor contractorsSelf employmentFreelanceWorldwideFlexible hours
- ...overseeing quality assurance activities and leading teams. The role includes managing inspection processes, ensuring adherence to ISO 13485, and handling customer complaints. The ideal candidate has at least 8 years in quality control with supervisory experience, strong...Suggested
- ...Revvity Health Sciences, Inc. is seeking a Quality Systems Specialist at their Hopkinton facility. This role focuses on managing the ISO 13485 Quality Management System by providing administrative support, coordinating training, and processing Change Orders. The ideal...Suggested
- GMED NA is seeking a Medical Device QA Auditor to join our team. This home-based position involves conducting ISO 13485/MDSAP audits and ensuring compliance with international standards for medical products. The ideal candidate will have a bachelor's degree in a related...Remote jobWork from home
- ...auditing, and cross-functional collaboration within an international team. The ideal candidate will possess strong knowledge of EN ISO 13485 and at least 3 years of relevant experience. The position promises competitive salary and performance bonuses in a fast-paced,...Suggested
- ...vergleichbaren Fachrichtung sowie mehrjährige Erfahrung im Programm-Management mit. Zusätzlich sollten Sie umfassende Kenntnisse der ISO 27001 sowie Kommunikationsfähigkeiten in Deutsch und Englisch mitbringen. Flexible Arbeitszeiten und umfassende Weiterbildungsmöglichkeiten...Remote jobFlexible hours
- Purdue University is seeking a Quality Specialist who will deliver consulting and training services for Quality Management Systems.... ...have significant experience in QMS, including the application of ISO standards. The position involves in-state travel and requires effective...Remote job
- ...Freelance ISO Lead Auditor / Consultant California Hybrid (with occasional on-site client visits)... ...network of 85 employees and more than 350 expert contractors enables us to deliver... ...A steady pipeline of client work Remote delivery with occasional on-site visits...Remote workContract workFor contractorsSelf employmentFreelanceWorldwideFlexible hours
- ...emphasizes strong hands-on experience in supplier qualification, management of Approved Supplier Lists (ASL), and compliance with ISO and FDA requirements. The ideal candidate will conduct supplier evaluations, oversee PPAP submissions for medical devices, and ensure...
- ...CAPAs, and ensuring compliance with regulatory standards such as ISO 13485. Ideal candidates will have a Bachelor's degree in a technical field and relevant experience in the medical device industry. Remote work is available with some travel required. Candidates should...Remote job
- ...Expert Biocompatibility Consultant Sotera Health Company is a leading global provider of mission-... ...compounds, and device use Apply ISO 10993 principles and FDA expectations to support... ...Information Work Arrangement: Fully remote (onsite presence as needed based...Remote workWork at officeWorldwide
- ...business. About the Role As a GRC Consultant at Network Coverage, you will... ...the role of subject matter expert, advising upon the on the most... ...frameworks such as NIST/CMMC, ISO 27001, HIPAA/Hitech, GDPR are... ...Work is primarily performed in a remote capacity and will require use...Remote jobWork at officeOverseasFlexible hoursShift work
- ...Cary, North Carolina, to support high-value payment processes. The ideal candidate should have substantial experience in payments and ISO 20022 standards, focusing on driving adoption and process enhancement. Responsibilities include analyzing business requirements,...
$90k - $120k
...The role requires a Bachelor's or Master's degree and a minimum of 6 years of experience in safety-critical systems. This is a fully remote position with a salary range of $90,000 - $120,000 and up to 20% travel. We value diversity in our workforce and welcome applicants...Remote job- ...extensive travel for on-site audits across Ohio, Michigan, and North Carolina. You will manage client portfolios and ensure compliance with ISO standards while supporting clients to achieve their business objectives. Candidates should have a college degree, relevant auditing...Remote workWork from homeFlexible hours
- Omniforce Solutions is looking for an experienced QMS Specialist in Houston, TX. The role involves administering the ISO 9001 Quality Management System, managing document control processes, and leading internal audits. Candidates should have 5-7 years of experience in QMS...
- ...Propulsion Support, Inc. is seeking a QC NDT Inspector Level II in Harrison, Ohio. The role focuses on ensuring compliance with FAA/EASA/ISO/AS standards while maintaining records and technical documents. The ideal candidate will have a minimum of three years of experience...
$75k - $90k
...culture of teamwork. Candidates should have a minimum of 3 years of experience in a machined parts environment and strong knowledge of ISO 9001:2015 and AS9100. The compensation ranges from $75,000 to $90,000, with benefits including health insurance and 401(k). #J-18808-...- ...ensure compliance and security oversight for a dedicated product/service within a dynamic team. The ideal candidate has experience with ISO 27001 and PCI DSS, strong leadership skills, and expertise in risk assessment. We provide opportunities for professional growth in a...
- A staffing agency in Oregon is seeking a Quality Assurance Technician to support product quality within an ISO-certified technical manufacturing environment. The role emphasizes non-conformance management, corrective actions, and root cause analysis. Ideal candidates will...
- ...corporate quality systems across our Germantown facility. The ideal candidate will execute quality projects and ensure compliance with ISO standards while reporting project updates. This role requires strong communication, attention to detail, and experience in regulated...
- ...Gate, California, is seeking a Quality Systems Engineer to develop and maintain a robust Quality Management System (QMS) aligned with ISO standards. The role involves driving quality culture and compliance, managing audits, and leading CAPA processes. With 15+ years of...
- ...Houston, TX. This role is pivotal in ensuring the conformity of safety-critical equipment through advanced inspections, compliance with ISO 9001, and mentoring of inspectors. You will lead inspection activities, support audits, interface with customers, and drive...
- ...specialty formulations company is seeking a Head of Quality Management based in Leuna, Germany. The role focuses on ensuring compliance with ISO 9001 and managing quality standards across Europe. Candidates must have over 5 years of experience in quality management within GMP-...
- ...a hands-on Quality Manager to oversee product and process quality in injection molding operations. This role ensures compliance with ISO 9001 and IATF 16949 standards while leading the quality department through startup and scale-up phases. The ideal candidate will have...
- ### Senior Consultant - CybersecurityPublicFull-time40 h/weekGermanyHybridStart date: As soon as possibleEnd date: No end dateYearly gross... ...cybersecurity certifications (for example Security+, CySA+, ISO 27001, CISSP, CCSP, CISM). Familiarity with local financial regulatory...Full timeWork at officeLocal area
- ...leading manufacturing firm in Tacoma is seeking a Quality Engineer to oversee the Quality Management System ensuring compliance with ISO standards. The role involves collaborating with teams to develop quality procedures, performing audits, and managing corrective actions...
- Planet Pharma Group is looking for a detail-oriented Quality Engineer to support quality systems and manufacturing processes. This role is crucial for ensuring compliance with industry standards in a regulated environment. The ideal candidate will have 2-5+ years of quality...
$120k - $145k
A leading engineering company in Bedford, MA is seeking a Quality Manager to oversee ISO certification processes, support new product development, and drive quality improvement initiatives. The ideal candidate should have a B.S. degree in Engineering, a minimum of 5 years...$75k - $156k
...cross-functional teams. You will work collaboratively to improve manufacturing and product efficiency while ensuring compliance with ISO standards. The position may require up to 20% travel within the United States and offers a competitive salary range of $75,000 - $156...
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