The Judge Group is seeking a Quality Engineer for a manufacturing company located in the Phoenix, AZ area.
Title: Quality Engineer
Location: Phoenix, AZ
Salary: $100k-$120k
Relocation : YES
Responsibilities
- Provide technical direction across medical device and pharmaceutical operations
- Develop, review, and investigate analytical testing methods for combination products
- Lead risk assessments, validations, and product investigations
- Oversee component qualification, stability programs, and change evaluations
- Convert design requirements into manufacturing and quality control plans
- Support audits, regulatory filings, and compliance initiatives
- Drive cross-functional development efforts and present project updates
- Manage timelines, budgets, and training activities
- BS in Engineering or related field (advanced degree preferred)
- 8+ years in medical device, pharma, or quality engineering
- Strong background in design controls and combination products
- Experience with validation, test methods, and statistical tools
- Knowledge of ISO 13485, ISO 14971, FDA (21 CFR), and ICH standards
- Skilled in risk analysis, root cause investigation, and process improvement
- Proven leadership, communication, and problem-solving abilities