A-Line Staffing is now hiring Medical Device Quality Engineer in Durham, NC. The Medical Device Quality Engineer would be working for a Major Medical Device company and has career growth potential.

Medical Device Quality Engineer Highlights:

• Schedule: Monday – Friday, 8:00 AM – 5:00 PM

• Pay Range: $45.14 Hourly

• Location: On-site daily – Locals Only

Medical Device Quality Engineer Responsibilities:

• Provide ongoing support for Manufacturing, focusing on engineering change projects and validation activities

• Serve as a key resource to manufacturing for improving product quality, reliability, and process capability

• Identify, document, assess, and help prevent quality issues using tools such as risk and root cause analysis

• Develop and implement reliability analysis, validation, and assessment methods for new test fixtures and sustaining changes

• Support validation planning and transfer activities for sustaining engineering and manufacturing functions

• Set operational quality goals and track performance metrics

• Lead and manage nonconformance records including CAPA determination, root cause identification, and documentation

• Promote a "quality first" culture across all activities

• Analyze and report on quality data to improve both product quality and manufacturing efficiency

• Provide regular updates to management and escalate issues as needed

Medical Device Quality Engineer Required Qualifications:

• Bachelor’s Degree in Mechanical, Electrical, Reliability Engineering, or related field

• Minimum 6 years of experience in a quality assurance role within a regulated environment

• Minimum 4 years of experience in medical device, automotive, or aerospace manufacturing

• Quality Certification preferred (e.g., CQE)

• Knowledge of ISO 9001 QMS; experience as a quality system auditor is a plus

• Familiarity with robotics, complex manufacturing systems, and large-scale electrical system assembly

• Excellent written and oral communication skills

• Strong leadership and influence abilities to lead cross-functional teams

• Results-oriented with strong problem-solving skills

If you are interested in this Medical Device Quality Engineer position, please apply to this posting with Luke Heuser at A-Line!