Senior Quality Engineer

Job Description

Pay Range: $40.17hr - $45.17hr

• The Quality Engineer 3 is responsible for consistently applying quality engineering principles, tools, and methodologies to support design control and production/process control activities.
• This role ensures compliance with regulatory, corporate, and unit quality requirements while supporting new product development and sustaining engineering initiatives.

• Consistently apply technical principles, theories, concepts, techniques, and quality sciences/tools.
• Utilize strong problem-solving skills to identify issues and implement effective solutions.
• Drive measurable improvements to processes and procedures.
• Ensure all design control and production/process control projects meet applicable local and international regulatory, corporate, and unit requirements.
• Act as a Quality representative on new product development and sustaining engineering projects.
• Review and provide Quality Engineering approval for new and modified design and process specifications, including product performance specifications and test methods.
• Assist with supplier and internal quality system audits to evaluate the effectiveness of the Quality System and Good Manufacturing Practices (auditor-in‑training).
• Perform other duties as assigned.

• Bachelor’s Degree in Science, Engineering, or a related discipline, or an equivalent combination of education and experience.
• Minimum of 5 years of relevant quality engineering experience.
• Applied knowledge of FDA medical device quality system regulations and international standards, including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR/IVDR.
• Ability to independently determine problem‑solving approaches and develop effective solutions.

• Experience contributing to quality programs and projects.
• Ability to ensure quality execution of projects including design, data analysis, interpretation, and report generation.
• Experience revising policies and procedures.
• Ability to provide guidance and direction to lower‑level project developers.
• Experience designing and performing development work independently within defined parameters with minimal supervision.

• Experience with client software systems used within Quality Systems.
• Experience supporting supplier and internal quality audits.
• Ability to create and deliver professional presentations.

• Acceptance sampling theory and application.
• Statistical process control methods and application.
• Measurement system and test method analysis.
• Quality planning and risk management.
• Failure analysis and investigation.
• Design of Experiments (DOE).
• Process mapping and value stream analysis.
• Hypothesis testing and descriptive statistics.
• Process capability analysis.
• Use of basic quality tools including Pareto charts, box plots, histograms, scatter diagrams, and similar techniques.
• Supplier quality management and auditing.
• Design and development tools.
• Process validation and software validation.

• Bachelor’s Degree in Science, Engineering, or a related discipline, or an equivalent combination of education and experience.