Quality Engineer III

Katalyst CRO; Franklin Lakes (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer to support new product development and ongoing maintenance for medical devices. You will apply quality engineering principles to ensure products meet design control and regulatory requirements.

Active involvement in audits, risk management, and process validation will be required. The role emphasizes collaboration with cross-functional teams, adherence to quality standards, and contribution to continuous improvement initiatives to support product quality and

Qualifications

• Bachelor's degree in science, engineering, or related field with 5+ years in quality engineering.
• Experience applying FDA QSR/21 CFR Part 820, ISO 13485, and related standards.
• Ability to lead design controls, risk management, and design reviews.

Responsibilities

• Support new product development from inception through launch and maintenance.
• Ensure design/control documentation meets regulatory requirements.
• Lead quality improvements across processes and supplier quality.
• Perform audits and contribute to CAPA and continuous improvement.

Skills

Quality Systems

Design Control

Risk Management

Auditing

Statistical Methods

Process Validation

Software Validation

Regulatory Compliance

Education

Bachelor's degree in science/engineering

5 years of relevant experience

Tools

Quality software systems

Job description

The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Responsibilities

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Proven problem-solving skills.
• Makes measurable improvements to Client processes and procedures.
• Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Acts as a team member representing Quality on new product development and sustaining engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
• Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).
• May perform other duties as required.

Requirements

Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of Client products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures
• Able to make presentations
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with Client software systems utilized in the Quality Systems is desirable.
• Acceptance sampling theory and application
• Statistical process control methods and application
• Measurement system/test method knowledge and analysis
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design/development tools
• Process validation
• Software validation