Quality Engineer
Joulé
Orangeburg, NY
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JOB DETAILS
SALARY
$38–$43 Per Hour
SKILLS
Biotech and Pharmaceutical, Change Requests/Orders, Clinical Laboratory, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Manufacturing, Marketing, Marketing Communications, Minitab, People Management, Process Validation, Product Design, Product Development, Product Documentation, Product Lifecycle, Product Support, Quality Engineering, Regulations, Research & Development (R&D), SAP, Sales
LOCATION
Orangeburg, NY
POSTED
30+ days ago
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.
- 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.
- 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.
- Support reagent stability studies, data review, and verification of shelf-life claims.
- Assist with product improvements and design?transfer activities within the lifecycle process.
- 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.
- 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.
Ref: #558-Scientific
About the Company
J
Joulé
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
- Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
- Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
- Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
- National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.
COMPANY SIZE
500 to 999 employeesINDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/