Quality Engineer III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This role calls for a hands-on professional with a robust background in quality, risk assessment, and CAPA investigations.  The ideal candidate will have a strong grasp of ISO and FDA quality frameworks and the ability to lead investigations, and continuous improvement initiatives across both development and production environments.
 

What will you do?

• Lead cross-functional team members supporting the Customer Feedback/Complaint Handling Process and CAPA process.
• Monitor product quality improvement to ensure execution of actions, including any resulting customer communications/interactions.
• Complete Risk and Impact Assessments.
• Interface directly with customers and internal groups.
• Develop realistic solutions to meet customer needs and solve problems.
• Drive product and process changes to improve product quality.
• Provide support to QE team members.
• Communicate recommendations and decisions across the organization.
• Apply problem-solving tools (8D, 5-whys, cause and effect, etc.).
• Demonstrate strong root cause/corrective action skills.

How will you get here?

Education:

• Bachelor’s degree in an Engineering or science related field required

Experience:

• 5 years of experience in an Engineering, Quality, or Regulatory capacity required (preferably within the medical device, biotech, or pharmaceutical sector)
• Direct experience working with ISO 13485, ISO 9001, and 21CFR820 required.

Knowledge, Skills, and Abilities:

• Strong analytical, problem-solving, and teamwork skills.
• Proficient with Microsoft tools (Word, Excel, PowerPoint, Visio, Teams) and MiniTab.
• Excellent written and verbal communication skills.
• Ability to analyze and process data and draw appropriate conclusions.
• Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
• Understanding of plastics materials, properties, manufacturing processes, and product assembly.
• Experience prioritizing conflicting demands.
• Excellent interpersonal, organizational, and influencing skills.
• ASQ certification is desired.