Quality Engineer - Medical Devices | PPAP & FAI

JBL Resources; Mahwah (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

JBL Resources, based in Mahwah, New Jersey, seeks a Quality Engineer to support QA, control, and preventative activities across operations. The role focuses on PDCA, process improvements, and regulatory compliance in medical device manufacturing.

You will lead PPAP, validation, and FAI activities, develop SOPs, and collaborate with cross-functional teams to ensure product quality and regulatory adherence. This is a hands-on, fast-paced role requiring strong problem-solving and communication

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering.
• Relevant experience in medical device manufacturing or a regulated environment.
• 1+ years of industry experience in quality engineering or a related field.
• Strong knowledge of Change Management and Quality Management Systems (QMS).
• Excellent communication skills, both written and oral.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Demonstrated problem-solving and analytical abilities.
• Ability to build strong stakeholder relationships.
• Self-starter with efficient multitasking skills in a fast-paced environment.
• Experience with validation activities and change control processes.
• Knowledge of engineering and quality concepts/ theories.

Responsibilities

• Providing quality engineering support in quality assurance, control, and preventative activities within operations and other business functions.
• Developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure that the products are free of flaws and function as designed.
• Advocating for and leading the execution of initiatives and projects to enhance quality performance within the business, while ensuring compliance with regulations and standards.
• Supporting product transfers and supplier change requests by coordinating necessary activities and documentation.
• Managing the Production Part Approval Process (PPAP) to verify and approve new or modified parts.
• Leading validation projects for new equipment and processes introduced to the plant.
• Developing, executing, and obtaining approvals for First Article Inspection (FAI) strategies.
• Creating and updating Standard Operating Procedures (SOPs) and inspection plans through the change management system.

Skills

Quality Engineering

Regulated environment

Root cause analysis

Documentation

Communication

Education

Bachelor's degree in Biomedical/Mechanical Engineering

Tools

Microsoft Word

Excel

PowerPoint

Job description

JBL Resources, based in Mahwah, New Jersey, seeks a Quality Engineer to support QA, control, and preventative activities across operations. The role focuses on PDCA, process improvements, and regulatory compliance in medical device manufacturing.

You will lead PPAP, validation, and FAI activities, develop SOPs, and collaborate with cross-functional teams to ensure product quality and regulatory adherence. This is a hands-on, fast-paced role requiring strong problem-solving and communication