We are hiring an Operations Quality Engineer to ensure product quality and compliance within the manufacturing environment in accordance with applicable regulatory requirements. The role supports production operations by managing quality issues, investigations, new product introductions, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in engineering (Mechanical, Industrial, Biomedical, or related field)
- 3 to 5 years of experience in Quality Engineering or Manufacturing Quality in a regulated industry
- Medical device experience strongly preferred
- Knowledge of quality system principles as outlined in FDA 21 CFR Part 820 and/or ISO 13485
- Strong problem-solving and root cause analysis skills
- Experience with lean manufacturing or continuous improvement methodologies is a plus
Benefits
- Medical Coverage
- Prescription Drug Coverage
- Telemedicine
- Dental Coverage
- Vision Coverage
- Employee Assistance Program
- Health Savings Account (HSA)
- Flexible Spending Account (FSA)
- Basic Term Life/AD&D Insurance
- Voluntary Life/AD&D Insurance
- Short Term Disability (STD)
- Long Term Disability (LTD)
- Voluntary Buy-Up LTD
- Hospital Indemnity
- Accident Insurance
- Critical Illness
- 401(k) Retirement Savings Plan
- Daily Pay
- Business Travel Insurance
- Legal Plan
- Identity Protection
