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Quality Engineer

Job in Upper Darby, Delaware County, Pennsylvania, 19082, USA
Listing for: CQ Medical
Full Time position
Listed on 2026-07-22
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Production QC/QA, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Salary/Wage Range or Industry Benchmark: 75000 - 115000 USD Yearly USD 75000.00 115000.00 YEAR
Job Description & How to Apply Below
Location: Upper Darby

The Quality Engineer is responsible for ensuring product quality, process capability, and manufacturing effectiveness through the application of quality engineering principles, risk‑based decision making, data analysis, and continuous improvement methodologies. This role serves as the primary quality partner to Manufacturing, Manufacturing Engineering, Sustaining Engineering, Research & Development, and Supply Chain teams to identify and mitigate quality risks, improve process performance, reduce cost of poor quality, and ensure compliance with applicable regulatory and quality system requirements.

The Quality Engineer provides technical leadership for nonconformance investigations, process validation activities, quality planning, inspection strategies, statistical analysis, and manufacturing quality improvement initiatives throughout the product lifecycle.

Essential Duties & Responsibilities Operational Quality Support
  • Serve as the primary Quality representative for assigned manufacturing processes, product families, or value streams.
  • Provide day‑to‑day quality engineering support to manufacturing operations.
  • Participate in production issue resolution and escalation activities.
  • Evaluate manufacturing quality performance and identify opportunities for improvement.
  • Support achievement of quality, delivery, and operational performance objectives.
Nonconformance & Investigation Support
  • Lead and facilitate investigations related to manufacturing nonconformances and product quality issues.
  • Apply structured root cause analysis methodologies to identify underlying causes of defects and failures.
  • Develop and implement effective corrective actions within assigned areas of responsibility.
  • Support Material Review Board (MRB) activities and disposition decisions.
  • Identify recurring trends and systemic quality issues requiring escalation.
Quality Planning & Risk Management
  • Participate in product and process risk assessments throughout the product lifecycle.
  • Support development and maintenance of risk management documentation.
  • Evaluate proposed process, material, equipment, and design changes for potential quality and compliance impacts.
  • Collaborate with cross‑functional teams to ensure quality considerations are incorporated into business decisions.
Process Validation & Verification
  • Support process validation and verification activities and revalidation efforts.
  • Assist in development of validation protocols and reports.
  • Evaluate process performance data to verify ongoing process effectiveness.
  • Support equipment qualification and process capability initiatives.
Inspection & Measurement Systems
  • Develop and maintain inspection strategies, acceptance criteria, and test methods.
  • Create and improve inspection methods, sampling plans, and quality controls.
  • Author and/or facilitate First Article Inspection documentation, coordination, and execution.
  • Evaluate effectiveness of measurement systems and inspection processes.
  • Assist with gage selection, measurement studies, and continuous improvement of inspection activities.
Data Analysis & Continuous Improvement
  • Analyze quality, manufacturing, and customer performance data to identify trends and improvement opportunities.
  • Utilize statistical tools and methodologies to support data‑driven decision making.
  • Lead or participate in continuous improvement projects focused on reducing defects, scrap, rework, complaints, and cost of poor quality.
  • Develop and maintain quality performance metrics and reporting.
Product Development & Change Management Support
  • Participate in new product development and product transfer activities.
  • Support design verification, validation, and manufacturing readiness activities as assigned.
  • Review engineering changes for potential quality impacts.
  • Collaborate with Configuration & Change Management personnel to ensure effective implementation of approved changes.
Regulatory & Quality System Compliance
  • Ensure assigned activities comply with applicable quality system and regulatory requirements.
  • Support internal and external audits as a subject‑matter expert.
  • Maintain accurate and complete quality records.
  • Promote a culture of quality, compliance, accountability, and continuous…
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