Quality Engineer

Title: Quality Engineer

Location: Phoenix, AZ

Our client, a leading global company specializing in custom packaging solutions for the medical device and pharmaceutical industries, is seeking a Quality Engineer for its Phoenix, AZ, location. The company focuses on designing and manufacturing high-quality packaging using advanced plastic manufacturing technology and stringent quality control measures.

Position Overview

Role: As the Quality Engineer, you would be responsible for collaborating with design and manufacturing to establish project quality standards, specifications, and inspection methods.

Key duties include maintaining and analyzing customer prints, requirements, and specifications to ensure customer requirements will be consistently met and supporting new product development and changes to customer specifications by writing protocols and analyzing results from 1 st article and Process validations (IQ-OQ-PQ) studies during product launch and subsequent changes to tooling or specifications and developing new inspection methods and product specifications for use during production. Training workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.

Responsibilities and Functions:

• Work with manufacturing and quality inspectors to contain and dispose of non-conforming products. Troubleshoots and participates in solving quality-related production problems. Recommends design and processing revisions to reduce actual or potential quality costs. Takes a lead role in facilitating and aiding in scrap reduction initiatives

• Assist in the development process, such as process improvement, problem-solving, AQL Levels, FMEA, validations (IQ/OQ/PQ), DOE, and metrics.

• Provide guidance/leadership/decision-making to the QA Department

• Assist in the development process, such as process improvement, pack out, AQL levels, control plan for inspection, validations, and Metrics.

• Participates and facilitates internal /external corrective action activities and ensures activities are properly tracked and documented.

• Ability to read and interpret engineering drawings and technical specifications.

• 1 st article process includes measurement, analysis, and reporting data.

Qualifications:

Education:

• BS, AS in Engineering or equivalent is preferred

Experience:

• Required:5-7 years of Quality Engineering experience in a Manufacturing environment, including validation and measurement analysis, or a combination of education and experience.

• ASQ Certified Quality Engineer (CQE) or other certification preferred

• Good math and PC skills. Working knowledge of statistical software (Minitab preferred)

• Excellent organizational and oral / written communication skills are required

• Formal training in procedures, ISO 13485 standard, and inspection methods and techniques

• Thermoforming and/or medical packaging experience is a plus.

Benefits:

• 401(k) match program

• Annual bonus

• Dental, health, and vision insurance

• Paid time off

Location: Phoenix, AZ

If you are interested in this position, please apply here or send your resume to [email protected].

Equal Opportunity Employer Disclaimer

This organization is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability status, genetic information, protected veteran status, or any other characteristic protected by applicable law. Employment decisions are based solely on qualifications, merit, and business needs.