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Remote Iso Document Control Jobs in Indiana (NOW HIRING)

Ruoff Mortgage

Remote DE FHA Underwriter

Fort Wayne, IN · Remote

$70K - $80K/yr

Respond to post-closing audits and quality control reviews * Assist with training of new ... Detail-oriented with strong recordkeeping and document retrieval skills Experience and Training ...

Ruoff Mortgage

Remote DE FHA Underwriter

Fort Wayne, IN · Remote

$70K - $80K/yr

Respond to post-closing audits and quality control reviews * Assist with training of new ... Detail-oriented with strong recordkeeping and document retrieval skills Experience and Training ...

Ledcor Group

Permitting Specialist

Indianapolis, IN · Remote

Oversees document control and ensures compliance with customer requirements * Any other ... This has the flexibility of being a remote position * This position will require 15% travel ...

ABB

Protection and Control Engineer

Evansville, IN · Remote

While this is a full remote position, there is preference for candidates located in the Northern ... Develop engineering documentation and perform analyses-such as schematics, logic diagrams, layouts ...

A.C. Coy

Java Developer front-end (Remote)

Indianapolis, IN · Remote

$48.75 - $63/hr

Follow US Federal Government security and development standards, documentation requirements, and ... Experience with version control tools (e.g., Git). * Familiarity with JSP, Tomcat, or related web ...

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All JobsIso Document Control JobsRemote Iso Document Control JobsRemote Iso Document Control Jobs in Indiana

Remote Iso Document Control information

What is the difference between Remote Iso Document Control vs Remote Quality Document Control?

AspectRemote Iso Document ControlRemote Quality Document Control
CertificationsISO standards knowledge, document management certificationsQuality management system certifications, document control certifications
Work EnvironmentPrimarily office or remote, industry-specificPrimarily office or remote, industry-specific
Industry UsageManufacturing, engineering, aerospaceManufacturing, healthcare, automotive
Search & ComparisonOften compared for ISO compliance rolesCompared for quality assurance roles

Remote Iso Document Control focuses on managing documents related to ISO standards compliance, ensuring proper documentation for certifications and audits. Remote Quality Document Control emphasizes maintaining quality management system documents across various industries. While both roles involve document management, Iso Document Control is more specialized in ISO standards, whereas Quality Document Control covers broader quality processes.

What are popular job titles related to Remote Iso Document Control jobs in Indiana? For Remote Iso Document Control jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Remote Iso Document Control jobs in Indiana look for? The top searched job categories for Remote Iso Document Control jobs in Indiana are:
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Remote Iso Document Control jobs near you

Design Quality Engineer

Prophecy Technologies

Indianapolis, IN • On-site, Remote

Full-time

Posted 7 days ago

Job description

Role Overview:
The Design Quality Engineer will play a crucial role in supporting quality activities throughout the medical device product development lifecycle. This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design History File (DHF) documentation and risk management processes.
Key Responsibilities:
  • Support quality activities throughout the product development lifecycle.
  • Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements.
  • Lead and support risk management activities including dFMEA, uFMEA, and PHA updates.
  • Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs.
  • Support Design Verification and Validation planning, execution, and documentation reviews.
  • Review Product Characterization, Product Specification (PSD), and CTQ documents.
  • Participate in design reviews and ensure compliance with Design Control processes.
  • Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages.
  • Conduct DHF gap assessments and support remediation activities.
  • Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams.
  • Support CAPA investigations, root cause analysis, and implementation of corrective actions.
  • Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures.
  • Support internal audits, customer audits, and regulatory inspections.
  • Drive continuous improvement initiatives related to design quality and risk management processes.

Required Skills:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.
  • Strong knowledge of Design Controls and medical device product development.
  • Experience with Design History File (DHF) development, review, and remediation.
  • Hands-on experience with Risk Management activities including: dFMEA, uFMEA, Preliminary Hazard Analysis (PHA).
  • Experience with Design Verification and Validation (V&V).
  • Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements.
  • Experience preparing and reviewing: Product Specification Documents (PSD), Product Characterization documents, CTQ (Critical-to-Quality) documents.
  • Experience with CAPA, Nonconformance, and root cause investigations.
  • Familiarity with PLM systems such as Windchill or Teamcenter.
  • Experience with Cockpit Cognition DHF Build and DHF traceability management.
  • Strong documentation, technical writing, and audit support skills.

Qualifications:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.

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