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