Overview
Quality Assurance Lead Jobs in Arlington, TX at Universal Pure, LLC
Job Title: Quality Engineer – Manufacturing
Location: North Haven, CT
Job Description:
We are seeking an experienced Quality Engineer – Manufacturing to support process validation, risk assessments, and non-conformance investigations within a highly regulated medical device manufacturing environment. The ideal candidate will have extensive experience in IQ, OQ, PQ, TMV, and PFMEA to ensure compliance with industry standards and regulatory requirements.
Key Responsibilities:Process Validation & Manufacturing Support
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Conduct Test Method Validation (TMV) and statistical data analysis for process improvement.
Support Process Failure Mode and Effects Analysis (PFMEA) and risk mitigation activities.
Risk Management & Quality Assurance
Perform Failure Mode and Effects Analysis (FMEA) for manufacturing processes and product designs.
Conduct Root Cause Analysis (RCA) and implement corrective and preventive actions (CAPA).
Drive Non-Conformance Reporting (NCR) investigations and resolutions.
Regulatory Compliance & Documentation
Prepare and maintain Risk Assessment documentation in compliance with FDA, ISO 13485, and Medtronic’s internal quality requirements.
Support SPGA (Supplier Process Gap Analysis) to ensure supplier compliance and continuous improvement.
Collaborate with cross-functional teams to drive continuous improvement initiatives within the manufacturing process.
Required Qualifications:
Bachelor’s or Master’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field).
7 – 20 years of experience in Quality Engineering within medical device manufacturing.
Strong expertise in Process Validation (IQ/OQ/PQ), TMV, and FMEA methodologies.
Experience handling CAPA, NCRs, RCA, and Risk Assessments in a regulated environment.
Proficiency with FDA, ISO 13485, and GMP regulations.
Excellent problem-solving, documentation, and communication skills.
Job Type: Contract
Pay: $47.61 – $50.16 per hour
Schedule:
Monday to Friday
Ability to Commute:
North Haven, CT 06473 (Required)
Ability to Relocate:
North Haven, CT 06473: Relocate before starting work (Required)
Work Location: In person
Title: Quality Assurance Lead
Company: Universal Pure, LLC
Location: Arlington, TX
