Quality Engineer ~ Tech Writer

IntePros

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree + 2 years of relevant experience, or Master’s degree with no experience
  • Experience in the medical device industry is required
  • Strong skills in technical writing
  • Proficient in data analysis
  • Capable of managing projects effectively

Responsibilities

  • Support risk assessments and design change quality reviews
  • Perform assessments on product quality and conduct root cause investigations
  • Review risk management files and engineering change documentation
  • Develop technical documents like Design Failure Mode Effect Analysis (DFMEAs)
  • Analyze data to back quality and process improvement initiatives
  • Collaborate with Engineering, Manufacturing, and other teams
  • Ensure adherence to medical device quality standards

Benefits

  • Hybrid work schedule (4 days onsite, 1 day remote)
  • Opportunity to collaborate across diverse teams
  • Engagement in meaningful quality and process improvement projects
  • Exposure to risk management and compliance in the medical device sector
Full Job Description
Quality Engineer - Technical Writing

The diversity of duties and skills may include technical writing (Design Failure Mode Effect Analysis, and other related technical documentation) to creative and critical thinking, working with diverse teams in resolving quality issues and process improvements.

Key Responsibilities:
  • Support risk assessments, design change quality reviews, and product quality issues
  • Perform product quality assessments and root cause investigations
  • Review risk management files and engineering change documentation
  • Develop technical documentation, including DFMEAs
  • Analyze data and support quality/process improvement projects
  • Collaborate cross-functionally with Engineering, Manufacturing, and other teams
  • Ensure compliance with medical device quality standards and requirements
Top 3 Skills:
  • Technical Writing
  • Data Analysis
  • Project Management
Qualifications:
  • Bachelor's degree + 2 years of relevant experience, or
  • Master's degree + 0 years of relevant experience
  • Medical device industry experience required
Schedule: 40 hours/week
Location: Hybrid - 4 days onsite, 1 day remote

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