Quality Engineer

Job Title: Quality Engineer
Location : Greater Orangeburg / Blauvelt, NY area
Duration : Contract 4-6 months
Schedule : Mon–Fri, 8 hour days (100% onsite)
Pay Rate: $38–43/hr
Start Date : ASAP

Role Overview
This organization is a global leader in specialized diagnostics, producing reagents, specialty assay kits, and consumables used in hemostasis, blood gas, and acute care testing. The Quality Engineer in this role will support the production of these diagnostic reagents and consumables with a strong focus on Process Validation, Measurement System Analysis (MSA), and quality system compliance within a regulated manufacturing environment.

This role is ideal for early-to-mid career Quality Engineers or experienced contractors seeking a hands-on, onsite 6-month assignment supporting process validation, QC investigations, and regulated manufacturing operations.

Key Responsibilities

Process Validation (Primary Focus)

• Lead and support Process Validation activities, including IQ/OQ/PQ for reagent manufacturing processes, equipment, and packaging operations.
• Develop, execute, and document process validation protocols and reports.
• Validate production steps related to hemostasis reagents and diagnostic kits.

Quality Control & MSA

• Perform Measurement System Analysis (MSA) and Gage R&R for QC instruments and analytical methods used in reagent potency and stability testing.
• Evaluate data trends and support improvements to QC measurement systems.

Nonconformance, Investigations & CAPA

• Support investigations into deviations, quality issues, and batch failures.
• Participate in root cause analysis and document corrective and preventive actions.
• Incoming Material & Supplier Quality
• Perform quality assessments of raw materials (buffers, chemicals, proteins) used in reagent manufacturing.
• Support supplier quality and material acceptability decisions.
• Documentation & Compliance
• Prepare and review validation protocols, SOPs, batch records, and technical reports.
• Ensure adherence to FDA, ISO 13485, and GMP quality system requirements.

Stability Testing & Product Support

• Support reagent stability studies, data review, and verification of shelf-life claims.
• Assist with product improvements and design?transfer activities within the lifecycle process.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related field.
• 2–5+ years in quality, validation, or manufacturing in diagnostics, medical devices, or reagent production.
• Experience with Process Validation, IQ/OQ/PQ, MSA, and quality tools.
• Strong analytical, documentation, and problem?solving skills.
• SAP, Minitab or CAPA experience a plus.

Impact of the Role

• Products manufactured at this site directly support critical clinical testing in hemostasis and blood gas analysis, making this Quality Engineer role essential for ensuring product accuracy, safety, and regulatory compliance.

#M3
Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.