Staff Quality Engineer (Process Validations)

About This Role

This Staff Quality Engineer provides critical quality engineering direction for new product development and sustaining projects, focusing on design and process validation, measurement systems analysis, and equipment and software validation, ensuring compliance with relevant regulations.

Responsibilities

• Lead Facilities, Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ) for new product introduction and sustaining engineering projects
• Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans
• Apply technical principles, theories, concepts, techniques and quality sciences / tools, and make procedural updates
• Act as Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files
• Establish a strong working relationship with operations to monitor and analyze in-process inspection, process control, waste, reject rates, environmental control, and customer complaints to lead continuous improvement projects
• Support appropriate CAPA activities to accomplish internal/external objectives
• Mentor associates in Quality system concepts and documentation

Requirements

• Strong knowledge of process validations and production and process controls
• Excellent leadership, communication, organization and project management skills
• Ability to make timely critical decisions regarding product quality and/or quality system compliance
• Expert understanding of quality engineering sciences and their application to Validation activities
• Thorough understanding of 21 CFR 820, MDSAP, ISO 13485, ISO 9001 and ISO 14971
• Ability to prepare and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies
• Ability to assess and articulate risk when evaluating a situation
• Ability to perform thorough investigations, identify root cause(s), and propose appropriate corrective action(s)
• Ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams
• Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry
• In-depth understanding of the application of QS to the medical device industry

Qualifications

• Bachelor's degree in science, engineering, or other relevant field
• Minimum of 5 years of quality assurance or relevant experience in the Medical Device or Bioscience industry, with significant experience in Process validation, FDA regulations and ISO requirements

Skills

* Required skills

Certifications