Principal 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 ten (10) to twelve (12) years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment. 
3. Six Sigma Greenbelt certified or equivalent knowledge.
4. Excellent written and verbal communication skills. 
5. Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, ISO14971, QSR, and MDD. 
6. Expertise/experience in root cause analysis, corrective/preventive action methods, and problem solving with quality tools such as: DMAIC / CAPA/ FMEA, 5 WHYs, MSA, SPC, etc.
7. Experience with risk assessment files (dFMEA, sFMEA).
8. Experience with engineering or supplier change process.
9. Audit experience in quality assurance activities for medical device and drug products. 
10. Experience with statistical techniques and process validations. 
11. Strong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creation.
12. Proficient with MS Word, Excel, Outlook, Teams, and statistical software.

1. Master's degree a plus.
2. PMP Certification
3. Six Sigma Black Belt Certified
4. ISO13485 Certified Lead Auditor
5. Certified Quality Engineer
6. Advanced understanding of verification & validation, statistical techniques, and risk management.

External-Facing Title

Principal Engineer, Supplier Quality

Posting Country

US - United States

Salary Range

$114,714 - $160,600 (Compensation may be higher/lower based on experience, education and skill sets)