Quality Assurance Engineer

Quality Assurance Engineer at Net2Source (N2S) Quality Assurance Engineer at Net2Source (N2S) in Mount Saint Joseph, Ohio Posted in about 24 hours ago.

Type:

full-time

Job Description:

Job Title:

Quality Assurance Engineer Duration:

12 months (Possible Extension)

Location:

Hebron, KY 41048

Job Description:

The Quality Assurance Engineer is part of the Process Validation Group, specializing in all types of validation deliverables. The Quality Assurance engineer is a key member of the PV team, reporting to the Senior Manager, Process Validation. You will collaborate with senior QA staff, taking responsibility for Process Validation Reagents within Reagent manufacturing. In this role, you will have the opportunity to: Write and conduct IOQ and spreadsheet validations. Complete

PQ, TMV, AQ

validations. Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards. The essential requirements of the job include: Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry. Familiarity with CFR 21 Part 820 and

ISO13485.

Proficiency in MS Excel and a good working knowledge of computer programming and systems. It would be a plus if you also possess previous experience in: Knowledge of

PQ, TMV, AQ, NPSV

validations. Exposure to Gamp5 or similar regulations. ASQ Certified Quality Engineer (CQE). Why Work with Us? We believe in more than just jobs-we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter. Our Commitment to Inclusion & Equity Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics. Awards & Recognition

• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts

INC 5000

List for Eight Consecutive Years

• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1