Quality Engineer II

Drives quality improvements and corrective actions for components sourced from external suppliers. Supports supplier selection, develops material acceptance criteria, and monitors supplier performance to address yield issues and field failures.

Key Responsibilities:

• Evaluate and qualify new suppliers for technical, quality, and manufacturing capabilities.
• Develop and maintain incoming inspection procedures; train inspectors.
• Identify and implement appropriate inspection tools and equipment.
• Assist in creating and reviewing component specifications.
• Generate test protocols, monitor testing, and approve components for use.
• Support Design Engineering with component selection and reliability analysis.
• Analyze material defects, drive corrective actions, and communicate with suppliers.
• Investigate field failures and implement corrective action plans.

Qualifications:

• BS in engineering or technical field with 2+ years of relevant experience.
• Background in regulated industries (medical device, automotive, aerospace, etc.).
• Familiarity with process validation, design controls, risk management, CAPA, SCAR.
• Strong organizational, communication, and project management skills.
• Able to learn and use software tools (PLM, ERP).
• Up to 25% domestic/international travel.

Preferred Qualifications:

• 3+ years in engineering within regulated industries.
• Experience in problem-solving, auditing (ISO 13485), or quality systems.

Additional Information:

• Works independently, with general supervision.
• Expected to apply judgment in problem-solving and contribute to team objectives.
• Communicates and presents data to internal teams effectively.

• Mid-Senior level

• Contract

• Research

• Medical Equipment Manufacturing