Quality Engineer II

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As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of quality engineering skills for medical devices. For new product development, this person will handle projects and tasks from product inception through launch and maintenance, and will actively ensure products meet quality standards consistent with corporate and unit policies while meeting all design control and regulatory requirements.

For sustaining product activities, the engineer will understand, improve, and control operational processes to realize predictable product flow while satisfying established client standards of quality. Successful performance requires close work with quality management, operations, suppliers, and client associates to assure compliance with all client quality policies, procedures, and practices.

• Support the plant on assigned product initiatives with technical expertise and determine associated resource needs.
• Provide critical quality engineering direction to projects with respect to quality tools and principles such as root cause analysis, FMEAs, risk mitigation, validation, DOE, measurement systems analysis, sampling, and control plans.
• Apply moderate technical principles, theories, and quality tools to solve problems.
• Develop solutions to routine problems of moderate scope.
• Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles, updating procedures as needed.
• Demonstrate working knowledge of applicable regulatory, corporate, and unit requirements.
• Represent Site Quality on product development projects and sustain engineering projects.
• Build strong working relationships with all levels of operations to monitor and analyze in‑process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels; lead continuous improvement projects.
• Approve protocols and reports for all validation and change control activities to ensure compliance with established procedures.
• Utilize Lean and Six Sigma methods, data analysis tools, and techniques to support validation efforts around continuous improvement.

• B.S. degree in Engineering (Industrial, Mechanical) or equivalent.
• 3+ years of quality experience including validation and quality engineering responsibilities.
• Demonstrated success with statistical and problem‑solving methodologies.
• Excellent knowledge of quality engineering principles and quality management as related to validation of medical devices.
• Proficient with Minitab or other statistical software, MS Word, Excel, and MS Project.

• Strong understanding of failure analysis, test methods, and engineering tolerances.
• Strong verbal, written, and interpersonal skills.
• Six Sigma certification desired.
• ASQ CQE certification.
• Working knowledge of 21
  
  CFR
  820, 21
  
  CFR
  210 & 21
  
  CFR
  211, ISO 13485.
• Project management experience.
• Certified Quality Engineer and Certified Quality Auditor (preferred).

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing