What are the responsibilities and job description for the Manufacturing Quality Engineer position at Intellectt Inc?
Job Title: DHF Specialist
Location: Warsaw, IN
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.
