QA-Report Reviewer

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

Join DDL and play a critical role in ensuring the accuracy and reliability of testing reports that help medical device and pharmaceutical companies across the globe bring their products to market. We are seeking a QA-Report Reviewer who is organized, detail-oriented, and an excellent communicator and who can think on their feet, solve problems with project managers, and adapt to different personalities and fast-paced deadlines. Candidates with experience in quality documentation, batch or lot release approvals, or testing labs, whether from medical device, pharma, or other industries, will make a strong impact in this role.

Who We Are

DDL, Inc. is a third-party testing facility dedicated to helping medical device and pharmaceutical companies across the globe bring products to market. For over 30 years, DDL has provided extraordinary customer service and specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries for our clients’ safety and efficacy testing. We help save lives by providing the highest standards for package, product and material testing.

“Working for DDL the past 8 years, I’ve gained life-long friendships with my co-workers.” – Angela – Packaging Project Manager/Engineer

“There is great daily satisfaction knowing the testing we perform is helping provide safe medical products all around the world.” – Brad – Packaging Project Manage r

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities)

The primary role of the Quality Assurance (QA) - Report Reviewer is to review and approve test reports for completeness and accuracy.

• 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
  

WHAT YOU NEED TO SUCCEED (Minimum Qualifications)

• 3 -5 years in testing lab environment or related field
• Technical understanding of test standards and contracts.
• Microsoft Office suite
• Detail oriented
• Strong verbal and written communication skills
• Team player
• Self-motivated
• Technical ability
• Strong organization skills

WHAT WILL SET YOU APART (Preferred Qualifications)

• Associates Degree in a technical field preferred

Why Join Us

If you’re a team player who is looking for a sense of accomplishment, the opportunity to grow both personally and professionally, and a place to call home, then DDL is the place for you! At DDL, Inc., we strive to offer a competitive salary along with a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
• Voluntary Life and AD&D
• Short-Term Disability
• Pet Insurance
• Commuter Transit Benefits
• 401(k) Retirement Plan w/Safe Harbor Employer Contribution
• Paid Holidays
• PTO

It is DDL, Inc.’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.