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Design Assurance Engineer

JBL Resources

Elkton, MD

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JOB DETAILS
SKILLS
Analysis Skills, Auditing, Best Practices, Biology, Change Control, Code of Federal Regulations, Component Selection, Computer Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Documentation Plan, Establish Priorities, Failure Mode and Effects Analysis (FMEA), Health Insurance, Healthcare, Healthcare Quality, Human Resources, ISO (International Organization for Standardization), Logistics, Maintain Compliance, Manufacturing, Mathematics, Medical Equipment, Medical Treatment, Mentoring, Metrology, Minitab, Performance Analysis, Problem Solving Skills, Process Control Engineering, Process Improvement, Product Development, Product Lifecycle, Product Reviews, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality Monitoring, Regulations, Regulatory Requirements, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Root Cause Analysis, Software Development, Standard Operating Procedures (SOP), Supply Chain Management, Supply Chain Operations, Technical Support, Technical/Engineering Design, Testability, Time Management, Training/Teaching, United States Department of Energy (DOE), Validation Documentation, Validation Plan, Vendor/Supplier Selection
LOCATION
Elkton, MD
POSTED
30+ days ago
NPD Quality Engineer
Location: Wilmington, Delaware
About Our Client:
Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility.  Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.
Key Responsibilities:
  • Representing Quality on product development teams to ensure compliance with internal procedures and U.S. and international regulatory requirements.
  • Leading quality system development and implementation throughout the product lifecycle.
  • Providing focused quality engineering support and driving timely execution of assigned project activities.
  • Leading Risk Management activities, including authoring risk management plans and reports, facilitating FMEA sessions, and ensuring risk assessments occur at appropriate project phases.
  • Leading master validation planning sessions and reviewing/approving validation and qualification documentation.
  • Reviewing and approving technical transfer plans and supporting design transfer activities to manufacturing
  • Providing input to material specifications, drawings, inspection procedures, and manufacturing documentation to ensure manufacturability and testability.
  • Overseeing metrology, incoming inspection, acceptance criteria, and disposition of non-conforming materials.
  • Participating in supplier selection and component specification reviews, and acting as a technical quality liaison for supplier-related issues.
  • Developing and validating quality test methods.
  • Establishing and leading corrective and preventive action (CAPA) plans and quality assurance strategies
  • Reviewing quality history, supplier controls, scrap analysis, and process controls to drive defect prevention initiatives.
  • Monitoring field quality performance, analyzing field returns, and determining root cause.
  • Tracking quality trends, managing corrective actions, and driving continuous improvement efforts
  • Generating and maintaining quality documentation including quality plans, SOPs, and inspection procedures.
  • Participating in Product Review Boards and leading investigations into internal and external complaints
  • Applying structured problem-solving methodologies to identify, prioritize, and resolve quality issues
  • Providing training and mentorship on quality system processes and best practices.
Qualifications:
  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.
  • 4–6 years of experience in Product Development or R&D within a regulated environment.
  • 6–10 years of progressive experience in a medical device quality assurance environment.
  • Strong working knowledge of engineering fundamentals and their application in product development and manufacturing.
  • Auditor experience preferred (1–2 years).
  • Demonstrated knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other applicable medical device regulations and standards.
  • Experience with quality tools and statistical methodologies including FMEA, DOE, SPC, and Minitab.
  • Experience supporting validation, design transfer, and risk-based change control processes.
  • Strong analytical, mathematical, and statistical capabilities.
  • Excellent computer proficiency.

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company

 

About the Company

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JBL Resources