ZipRecruiter

Log In

Dhf

60 jobs near Columbus, OH

CYNET SYSTEMS

Senior Quality Engineer

Maple Grove, MN · On-site

$58/hr

The position supports Project Guardian DHF remediation and Design Assurance specific activities. Requirement/Must Have: * At least 3 years of experience in the medical device industry. * Functional ...

Talent Software Services

Quality Engineer III

Maple Grove, MN · On-site

$75K - $97K/yr

Key Responsibilities Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control deficiencies ...

PSG Global Solutions

R-D Engineer

Mansfield, MA

Lead full DHF remediation in accordance with relevant internal SOPs and Design Control. Effectively communicate and work cooperatively with others as part of a team. Share information, status, needs ...

LanceSoft

Systems Design Engineer

Salt Lake City, UT · On-site +1

$96K - $132K/yr

Draft and maintain DHF content including user needs, system/design requirements, design inputs, traceability matrices, and risk documentation * Define clear, testable requirements and support ...

LanceSoft

Systems Design Engineer

Salt Lake City, UT · On-site +1

$96K - $132K/yr

Draft and maintain DHF content including user needs, system/design requirements, design inputs, traceability matrices, and risk documentation * Define clear, testable requirements and support ...

PSG Global Solutions

R-D Engineer

Chicopee, MA

Lead full DHF remediation in accordance with relevant internal SOPs and Design Control. Effectively communicate and work cooperatively with others as part of a team. Share information, status, needs ...

next page

Showing results 1-20

Senior Quality Assurance Engineer

Senior Quality Assurance Engineer

Katalyst

Mundelein, IL • On-site

Other

Posted 8 days ago

Job description

Job Summary :

The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements.This role plays a key part in guiding design controls, facilitating design transfer, and managing risk documentation across medical device product lines (Class I and Class II 510(k)). The engineer will ensure that all processes and documentation meet FDA and ISO standards, and that design changes are properly controlled and documented.

Roles & Responsibilities :

  • Conduct end-to-end DHF audit and gap assessment , including:
    • Design & Development Plan
    • User Needs
    • Design Inputs & Outputs
    • Design Verification & Validation (V&V)
    • Risk Management Files (ISO 14971)
    • Design Reviews and Traceability
  • Evaluate traceability across DHF elements (Inputs → Outputs → V&V → Risk)
  • Identify missing, weak, or non-compliant documentation
  • Deliver audit-defensible gap assessment reports with actionable remediation recommendations
  • Assess regulatory gaps versus procedural non-conformities
  • Work with partially remediated or legacy DHFs

Education & Experience :

  • Strong expertise in Medical Device Design Controls (21 CFR 820.30, ISO 13485)
  • Hands-on experience in reviewing and auditing DHFs (not just document authoring)
  • In-depth knowledge of ISO 14971 risk management (hazards, controls, residual risk)
  • Experience supporting DHF remediation in response to:
  • Strong ability to assess traceability and consistency across documentation
  • Experience identifying regulatory compliance gaps
  • Senior-level Quality or Regulatory professional
  • Prior experience as: DHF Auditor / Reviewer
  • Design Controls SME
  • Quality Engineer in FDA-regulated medical devices
  • Ability to work independently and communicate findings clearly
  • Strong documentation and report-writing skills
  • Focus is on analysis and gap identification , not document rewriting

Apply