Quality Engineer

Synerfac Technical Staffing; Clayton (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Synerfac Technical Staffing is sourcing a Quality Engineer for a contract role in the Raleigh area, working at a medical device manufacturer. The position sits at the intersection of production and quality, driving product compliance, process improvement, and day-to-day manufacturing quality in a regulated environment.

The role requires 2–5 years in Quality Engineering within a regulated industry, familiarity with CAPA, and strong problem-solving and communication skills.

Qualifications

• 2 to 5 years of experience in Quality Engineering or Manufacturing Quality within a regulated industry.
• 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

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

Skills

Quality engineering

Root cause analysis

CAPA

Regulatory documents

Communication skills

Product transfers

Education

Bachelor's degree in Engineering

Job description

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

Job Requirements

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