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.