Quality Engineer ~ Tech Writer

IntePros; North Haven (CT); Hybrid; USD 85,000 - 110,000; Full time

Job summary

IntePros seeks a Quality Engineer – Technical Writing to drive technical documentation and risk-based quality improvements. Hybrid work arrangement allows 4 days onsite and 1 day remote, located in Connecticut, United States.

The role emphasizes DFMEAs, design change QA, and cross-functional collaboration to resolve quality issues while ensuring compliance with medical device standards.

Qualifications

• Bachelor’s degree with 2+ years of relevant experience or Master’s degree with minimal experience required.
• Medical device industry experience is required.
• Experience with design controls and DFMEAs is preferred.

Responsibilities

• Support risk assessments and quality reviews for design changes and product quality issues.
• Conduct product quality assessments and root cause investigations.
• Review risk management files and engineering change documentation.
• Develop technical documentation, including DFMEAs and related records.
• Analyze data and support quality/process improvement projects.
• Collaborate with Engineering, Manufacturing, and other teams.
• Ensure compliance with medical device quality standards and requirements.

Skills

Technical Writing

Data Analysis

Project Management

Education

Bachelor’s degree + 2 years relevant experience

Master’s degree + 0 years relevant experience

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