Quality Engineer

This role sits at the center of production and quality, giving someone the chance to make a real impact on product compliance, process improvement, and day-to-day manufacturing quality in a regulated manufacturing environment. Quality Engineer Requirements: - 2 to 5 years of experience in Quality Engineering or Manufacturing Quality within a regulated industry, medical device experience strongly preferred.

Our client is a growing medical device manufacturer in the Raleigh area looking for a Quality Engineer to join their team on a contract basis. This role sits at the center of production and quality, giving someone the chance to make a real impact on product compliance, process improvement, and day-to-day manufacturing quality in a regulated manufacturing environment.

Quality Engineer Responsibilities:

-Lead and support quality issue management, including investigation, containment, and resolution of complaints and nonconformances

- Drive root cause analysis and corrective action activities, ensuring proper disposition and documentation

- Support new product introductions and product transfers, ensuring manufacturing readiness and compliance with quality requirements

- Partner with Operations and Engineering on continuous improvement projects, process validations, and manufacturing quality initiatives

- Analyze and report on quality metrics and trends to support production and quality planning





Quality Engineer Requirements:

- 2 to 5 years of experience in Quality Engineering or Manufacturing Quality within a regulated industry, medical device experience strongly preferred

- Knowledge of quality system principles, along with experience in nonconformance reporting, complaint handling, and CAPA processes

- Familiarity with new product introduction and product transfer processes; strong problem-solving and root cause analysis skills

- Strong verbal and written communication skills, with the ability to interpret technical drawings and regulatory documents

- Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field) preferred