Duration: 24 months
Schedule: Night Shift, rotating 2-2-3 schedule
Benefits: Medical, Dental, Holiday, PTO 401K matching
Seeking an Associate Quality Engineer to support quality and manufacturing processes for medical devices in a regulated environment.
Key Responsibilities:
Lead root cause investigations for manufacturing issues and customer complaints.
Develop and implement corrective/preventive actions and monitor effectiveness.
Troubleshoot customer-returned devices and manufacturing nonconformities.
Analyze product performance using statistical and risk-based approaches.
Support quality projects and collaborate with cross-functional teams.
Prepare technical documentation and communicate complex issues and solutions.
Ensure compliance with FDA, ISO 13485, and Quality System requirements.
Requirements:
0–2 years of experience in medical device/pharmaceutical regulated industries.
Bachelor’s degree in Engineering or Physical Sciences required.
Strong critical thinking, prioritization, communication, root cause analysis, and data analysis skills.
Engineering degree and ASQ certification (CQA, CQE, CQM) preferred.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!