QA Report Reviewer: Precision in Medical Testing

DDL, Inc. - Medical Device Package, Product and Material Testing; Eden Prairie (MN); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Voluntary Accident, Critical Illness,和

Job summary

DDL, Inc. is seeking a QA-Report Reviewer to review and approve test reports for completeness and accuracy in a fast-paced laboratory setting. You will ensure signatures, data integrity, and contract compliance across medical device and pharmaceutical projects.

Ideal candidates have 3–5 years in testing labs, strong communication, and proficiency with ISO/IEC 17025 and 21 CFR sections. We offer comprehensive benefits and a collaborative team environment in Eden Prairie, MN.

Qualifications

• 3 -5 years in testing lab environment or related field.
• Technical understanding of test standards and contracts.
• Microsoft Office suite

Responsibilities

• Review test reports, letters and data sheets for completeness and accuracy per test standards and test contracts.
• Ensure review activities, approvals, corrections, and electronic or handwritten signatures are documented contemporaneously and retained in accordance with data-integrity, record-control, and document-control requirements.
• Track and trend recurring report errors, review comments, correction cycles, and approval delays; communicate findings and recommend corrective, preventive, or process-improvement actions to improve first-pass quality and report turnaround time
• Maintain and apply current working knowledge of relevant applicable ISO/IEC 17025 requirements, applicable and relevant portions of 21 CFR Parts 211 and 820, approved procedures, customer requirements, and test standards/methods when reviewing and approving reports.
• Other duties as assigned

Skills

Detail oriented

Strong verbal and writtencommunication

Team player

Self-motivated

Technical ability

Strong organization skills

Education

Associates Degree in a technical field

Tools

Microsoft Office

Job description

DDL, Inc. is seeking a QA-Report Reviewer to review and approve test reports for completeness and accuracy in a fast-paced laboratory setting. You will ensure signatures, data integrity, and contract compliance across medical device and pharmaceutical projects.

Ideal candidates have 3–5 years in testing labs, strong communication, and proficiency with ISO/IEC 17025 and 21 CFR sections. We offer comprehensive benefits and a collaborative team environment in Eden Prairie, MN.