Job Details
Join a publicly-traded MedDevice manufacturer with ~10,000 employees globally.
- Making products that save people's lives!
- This plant recently underwent a $10M investment and is a Center of Excellence.
- The company really values integrity, excellence, and transparency. And they treat their employees well.
- Lots of growth potential. The company loves to promote internally!
Job Title: Quality Engineer III
Company: Publicly-traded, global Medical Device manufacturer that values excellence, integrity, and transparency.
Location: Roanoke, VA. Relocation assistance available.
Compensation: $100k - $115k + 8% bonus
Job Summary: The Quality Engineer will provide support for manufacturing operations to ensure that the manufacturing Quality Systems requirements are met. Will provide work with a team of other engineers, technicians, and inspectors. Supports regulatory and agency inspections, audits, investigations, and inquiries. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
Job Requirements:
- Bachelor's Degree in Engineering, Mathematics, Statistics or similar. Master's preferred.
- 3+ years of experience in Quality Assurance and Compliance in an ISO 13485 or 9001 (13485 preferred) MANUFACTURING environment
- Must be strongly experienced in FMEAs (Failure Mode and Effect Analysis)
- Clean room experience desired.
- Deep experience in process or equipment validation.
- NPI experience.
- Proficient in Office and Minitab.
- Experienced in Statistical Analysis / Root Cause Analysis
PLEASE BE AWARE:
- This is NOT a software role.
- This is NOT an automation role.
- Candidates MUST have MANUFACTURING Quality experience. We are NOT looking for candidates out of Software, Insurance, Healthcare.
- Candidates must have full-time US work authorization (i.e. Green Card, US Citizen) to be considered.