Quality Engineer; Medical OR Pharma FDA & Strong Technical writing

Position: Quality Engineer (Medical OR Pharma With FDA & Strong Technical Writing)

Location: Tempe, AZ

Duration: 6+ Months Contract

Hours: 40 hours per week

Shift: 1st Shift

Client: Medical Device Company

Job Category: Engineering

Experience Level: Mid-Seniority

Employment Type: Contract on W2 (US Citizens or GC Holders only)

Qualifications:

• Medical Device or Pharma experience required
• At least 3 years experience in quality engineering
• Knowledge of FDA and ISO requirements
• Strong technical writing skills for documentation
• Basic knowledge of quality engineering policies, principles and best practices
• Basic understanding of regulatory requirements (cGMP, FDA, ISO, etc.)
• Basic statistical sample size calculations for quality determination on simple projects

Responsibilities:

• Evaluate and control product and service quality.
• Work cross-functionally on development and maintenance of products or services.
• Resolve equipment and process‑related production issues, including equipment, process, materials and method validation.
• Conduct statistical analysis and metrics to evaluate systems and processes.
• Write test protocols, perform tests, collect data, and write reports to validate against plans and ensure product is used as intended.
• Apply knowledge and skills to complete own work, while dependent on others for instruction, guidance and direction when necessary.
• Develop competence in own area by performing routine work.