Job Description

Hello,

One of my clients is currently looking for a DHF Remediation Specialist. If you're interested or if your skills align with the role, please share your updated resume with me at [email protected] or contact me directly at (732) 838-4956 .

Title: DHF Remediation Specialist

Location: Warsaw, IN (Remote)

Duration : Long Term Contract (W2)

Key Responsibilities:

• Collaborate on DHF remediation projects , ensuring compliance with applicable regulations and standards.
• Utilize expertise in VAULT systems to effectively manage documentation and workflows.
• Author, review, and execute Design History File (DHF) documents for medical devices, maintaining thorough accuracy and quality.
• Support Research & Development (R&D) or Sustaining Engineering initiatives to enhance product performance and ensure lifecycle continuity.
• Maintain alignment with regulatory requirements and implement improvements within DHF processes.

Required Qualifications:

• Proven experience in DHF remediation within the medical device industry.
• Proficiency with VAULT systems is essential.
• Strong background in DHF document authoring and execution for medical devices.
• Hands-on experience in R&D product development or sustaining engineering roles.
• Excellent organizational and communication skills to coordinate with cross-functional teams.

Preferred Skills:

• Knowledge of medical device regulatory standards.
• Ability to identify gaps in existing DHFs and strategize corrective actions.
• Proficiency in relevant documentation tools and software.

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