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Remote Quality Engineer Medical Device Jobs in Indiana

BSI Group

... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ... Quality management experience including significant participation in third party quality audits

BSI Prof Serv EHS West

... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ... Quality management experience including significant participation in third party quality audits

SQA Services

Quality Auditor - Pharmaceutical

Warren, IN · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Assure quality in the supply chains of various clients within the pharmaceutical, medical device ...

SQA Services

Quality Auditor - Pharmaceutical

Carmel, IN · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Assure quality in the supply chains of various clients within the pharmaceutical, medical device ...

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Remote Quality Engineer Medical Device information

What does a remote quality engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

What are the key skills and qualifications needed to thrive as a remote quality engineer in medical devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

How does a remote quality engineer in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.
What are the most commonly searched types of Quality Engineer Medical Device jobs in Indiana? The most popular types of Quality Engineer Medical Device jobs in Indiana are:
What are popular job titles related to Remote Quality Engineer Medical Device jobs in Indiana? For Remote Quality Engineer Medical Device jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Remote Quality Engineer Medical Device jobs in Indiana look for? The top searched job categories for Remote Quality Engineer Medical Device jobs in Indiana are:
What cities in Indiana are hiring for Remote Quality Engineer Medical Device jobs? Cities in Indiana with the most Remote Quality Engineer Medical Device job openings:
Remote Quality Engineer Medical Device jobs near you
Infographic showing various Remote Quality Engineer Medical Device job openings in Indiana as of July 2026, with employment types broken down into 75% Full Time, 7% Part Time, 3% Temporary, and 15% Contract. Highlights an 100% Remote job distribution.

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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