Quality Engineer

About the role

The Quality Engineer is responsible for determining production standards, establishing quality control systems, and setting product requirement rules.

What you'll do

Duties/Responsibilities:

• Implements audits throughout the supply chain, ensuring quality standards, safety and legal requirements, and company policies and specifications are met.
• Collaborates with clients, customers, and other stakeholders to identify and resolve problems with delivered products.
• Conducts or assists with performance and failure analysis of defective products or materials; identifies, recommends, or executes corrective actions.
• Provides quality engineering support for in-progress and final acceptance projects.
• Owner of process validations (IQ, OQ, PQ) and machine qualifications
• Develops and maintains a system to track and report projects and results of quality awareness programs and initiatives.
• Owner of DOE (Design of Experiments) and statistical analysis
• Drafts and recommends procedures to establish or improve quality standards, standard repairs, process controls, and inspection methods.
• Analyzes, reviews, and approves quality engineering policies, processes, documentation, and operations.
• Develops and implements strategies to increase quality and customization of products.
• Oversees data collection, analysis, validation and other research for quality projects.
• Interact with customers and suppliers on quality related issues.
• Facilitate problem solving and continuous improvement activities
• Develop and maintain process/product controls including process/equipment validations.
• Support supplier development for adequate controls and processes to assure product quality.
• Performs other duties as assigned.

Qualifications

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong presentation, facilitation, and interpersonal skills.
• Preferred ASQ Six Sigma Green Belt and CQE certifications.
• Proficient with Microsoft Office Suite or related software.
• Minimum three years of related pharmaceutical manufacturing or other FDA regulated experience required.

Education and Experience:

Bachelor’s degree in Engineering; Quality, IE, or ME required