Quality Engineer II

Responsibilities

• Support the plant on assigned product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
• Provide critical quality engineering direction to Project Pearl with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
• Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences / tools.
• Develops solutions to routine problems of moderate scope.
• Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Makes basic procedural updates.
• Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.
• Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.
• Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.
• Average approval protocols and reports for all validation and change control activities to ensure compliance to established procedures.
• Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.

Requirements

• B.S. degree in Engineering (Industrial, Mechanic) or similar
• 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
• Demonstrate success with statistical and problem-solving methodologies.
• Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
• Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.

Preferred Requirements

• Strong understanding of failure analysis, test methods and engineering tolerances.
• Strong verbal, written and interpersonal skills.
• Six Sigma Certification Desired.
• ASQ CQE
• Working knowledge of 21CFR820, 21CFR210 & 21CFR211 ISO 13485.
• Project Management experience.
• Certified Quality Engineer and Certified Quality Auditor (preferred).