Quality Engineer - Medical Device Validation

Intellectt INC; Grover Hill (OH); On-site; USD 61,000 - 69,000; Full time

Job summary

Intellectt INC is seeking a Quality Engineer to support Manufacturing Quality Operations in a medical device setting in Ohio. The candidate will review validation and manufacturing documentation, analyze statistics, and identify gaps to ensure quality and compliance.

Responsibilities include evaluating data, supporting equipment qualification, and collaborating with cross-functional teams to resolve quality gaps. Strong technical writing and knowledge of Design Controls are required.

Qualifications

• Experience reviewing validation and manufacturing documentation.
• Strong writing and document review skills.
• Familiarity with statistical analyses and data trends.
• Knowledge of PFMEA, Control Plans and validation reports.

Responsibilities

• Review validation, characterization, and manufacturing documentation for accuracy and compliance.
• Evaluate statistical analyses, process capability data, and technical reports.
• Identify data abnormalities, documentation gaps, and unsupported conclusions.
• Review equipment and process characterization reports.
• Evaluate acceptance criteria and technical conclusions.
• Support manufacturing quality and process improvement activities.
• Partner with cross-functional teams to resolve documentation and quality gaps.
• Support equipment qualification and validation activities as needed.

Skills

Design Controls

Manufacturing processes

Technical writing

Statistical analysis

Process validation

Documentation review

Quality systems

Tools

PFMEA

Control Plans

URS

IQ/OQ/PQ

Job description

Intellectt INC is seeking a Quality Engineer to support Manufacturing Quality Operations in a medical device setting in Ohio. The candidate will review validation and manufacturing documentation, analyze statistics, and identify gaps to ensure quality and compliance.

Responsibilities include evaluating data, supporting equipment qualification, and collaborating with cross-functional teams to resolve quality gaps. Strong technical writing and knowledge of Design Controls are required.