Quality Engineer

Staff Quality Engineer

A BS in engineering from an accredited engineering or relevant science/technical school is required. A relevant advanced degree is preferred.

Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.

Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).

Leading or contributing to the reliability assessments of product design.

Leading and/or contributing to root cause investigations using various problem-solving techniques and tools (Ex. K-T analysis) and assesses effectiveness of corrective actions.

Conducting and supporting the development of test methods in equipment, process, and product qualifications/validations.

Developing, implementing, and/or maintaining process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.

Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics). Perform or guide Measurement Systems Analysis (MSA).

Mentoring others in various technical capabilities.

Interpreting standard and non-standard sampling plans.

Participating in technical reviews as appropriate.

Supporting execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.

The Staff Quality Engineer shall have or be working on a Black Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).

Certifications
- Certified Quality Engineer from ASQ is expected. Additional certifications are preferred.

The Staff Quality Engineer is expected to continue growth and be able to function in the following technical quality areas with minimal input:

Advanced knowledge of Quality Engineering/Scientific Method techniques and principles. Applied statistics of increasing complexity

Strong technical understanding of manufacturing equipment and processes.

Understanding of new product or process introduction processes, and expertise in process qualifications/validations.

Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards).

Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.

Design control

Process Validation (IQ/OQ/PQ)

Good documentation practices

Good manufacturing practices

Organizational requirements

Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations
- The Staff Quality Engineer will be able to take more complex CAPA issues and drive to completion.

Plan and perform basic reliability testing and analysis.

Experience managing projects and demonstrating project leadership abilities.

Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software

Learn and apply software packages as required

A total of 5 - 10 years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.

Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plans and conducts projects with moderate to high technical responsibility, complexity, or strategic input. Receives summary instructions from technical Quality leaders at various levels, in addition to other functional stakeholders.

The Staff QE supports the application of quality engineering and quality compliance in support of demanding projects. The Staff QE may also be involved with Quality Systems initiatives as a primary assignment or additional assignment.

New Product and/or Process Introduction

Business improvement

Life Cycle Engineering

The Staff Quality Engineer will generally operate more independently and will generally mentor or coach less experienced QEs.

Office deskwork, requiring sitting, walking, reaching, stooping, bending, using phone, keyboard and computer

Able to lift boxes up to 20 pounds

Able to focus for extended periods of time on detailed work