Quality Engineer III: Process & Compliance Leader

Werfen; San Diego (CA); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k with employer match

Paid vacation

Sick leave

Job summary

Werfen is seeking a Quality Engineer III to create quality system documents and lead diverse quality engineering activities across R&D, manufacturing, and supplier domains. The role emphasizes risk assessment, CAPA, and validation projects, with strong emphasis on statistics and process control.

The annual base salary ranges from $100,000 to $125,000 and is bonus-eligible. Employee benefits include medical/dental/vision, 401k with employer match, paid vacation, and sick leave.

Qualifications

• Bachelor’s degree, or equivalent, plus a minimum of (3) to five to (5) year previous experience, preferably within a regulated medical device or pharmaceutical environment
• ASQ certification and/or Six Sigma Green/Black belt preferred
• Broad knowledge of quality engineering principles and regulations

Responsibilities

• Write, review, and approve quality system documents.
• Participate and/or lead process validation teams.
• Investigate non-conformances, identify root cause, and implement corrective action plans.
• Support design control projects to meet requirements and maintain compliance.
• Participate in internal and external audits.
• Conduct risk and trend evaluations for product non-conformances.
• Prepare microbiology/sterility reports and recommendations as needed.
• Collaborate with manufacturing, R&D, Service, Distribution, Marketing for CAPA actions.
• Review change orders for product performance and labeling as required.
• Interpret regulations to ensure auditable documentation and regulatory readiness.
• Prioritize urgent matters as needed

Skills

Quality engineering

GMPs

DOE

Statistics

Validation

CAPA

Regulatory compliance

Documentation

Cross-functional

Problem solving

Education

Bachelor’s degree, or equivalent

Tools

MS Excel

Statistical software

ERP systems

Minitab

Job description

Werfen is seeking a Quality Engineer III to create quality system documents and lead diverse quality engineering activities across R&D, manufacturing, and supplier domains. The role emphasizes risk assessment, CAPA, and validation projects, with strong emphasis on statistics and process control.

The annual base salary ranges from $100,000 to $125,000 and is bonus-eligible. Employee benefits include medical/dental/vision, 401k with employer match, paid vacation, and sick leave.