Sr. Engineer, Supplier Quality

Location

Aliso Viejo, California, USA

Department Name

327-Indirect Manufacturing-Process Engineering

Qualifications

1. Bachelor’s Degree in Engineering or a related science discipline. 
2. Minimum of four (4) years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment. 
3. Strong written and verbal communication skills. 
4. Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, QSR, MDD. 
5. Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA, 5 WHYs etc. 
6. Audit experience in quality assurance activities for medical device and drug products. 
7. Experience with Root Cause Analysis, Corrective and Preventive Action methods. 
8. Experience with process validations. 
9. Proficient with MS Word, Excel, Outlook, and Teams. 

1. Good stakeholder management skills (Procurement, Q&R, R&D). 
2. Project management experience.

External-Facing Title

Sr. Engineer, Supplier Quality

Posting Country

US - United States

Salary Range

$100,000 - $131,000 (Compensation may be higher/lower based on experience, education and skill sets)