Quality Systems Engineer III
$82,100–$82,100 year
On-siteQuincy, Massachusetts, United States
Job Summary
Develop and maintain quality engineering methodologies, systems, and practices that meet regulatory and customer requirements. Serve as the quality representative to promote awareness and communication of quality initiatives across departmental, functional, and corporate teams. Identify and implement process control systems to support product development, qualification, and manufacturing performance. Lead the implementation of quality assurance activities, process controls, and CAPA systems while partnering with cross-functional teams throughout the product life cycle. Apply systematic problem-solving methodologies to resolve quality issues and organize data to influence stakeholder decision-making. Maintain compliance with the Quality Policy and documented procedures, demonstrating a primary commitment to patient safety. Support continuous improvement initiatives that enhance product quality and operational effectiveness.
Required Qualifications
- Bachelor's degree in engineering or a related technical discipline
- Solid knowledge of quality engineering principles, methodologies and quality system requirements
- Working knowledge of process controls, CAPA, root cause analysis and continuous improvement methodologies
- Ability to analyze technical problems, evaluate alternatives and implement effective solutions
- Strong written and verbal communication skills with the ability to present technical information clearly to internal audiences
- Ability to organize and analyze data to support quality and business decisions
- Ability to work effectively on cross-functional teams and build collaborative relationships
- Willingness and ability to travel between Quincy, Massachusetts, and Plainfield, Indiana, during the first year of employment
- Knowledge of applicable regulatory standards and quality system requirements
- Experience supporting process validation, risk management and continuous improvement initiatives
Desired Qualifications
- Experience supporting new product development, manufacturing operations or quality systems within a regulated industry
- Experience working in a medical device, pharmaceutical or other FDA-regulated environment
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