Validation Quality Engineer

Position Details:

Job Description:

• The Quality Engineer is responsible for supporting sustaining activities through the application of Quality Engineering skills for medical devices.
• This person will understand, improve, and control operational processes to realize predictable product flow.
• Additional responsibilities include cross-functional support for the Quality Engineering and Quality Systems group.
• This position is responsible for building sound technical and organizational competence within the area of responsibility. :
• 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 Branding projects 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.
• Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Is an extended team member representing Site Quality on new 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 in order to take a lead role in identifying and documenting 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 problem-solving methods, data analysis tools, and techniques to support department validation efforts around continuous improvement.

Experience & Education:

• S. degree in Engineering (Industrial, Mechanic) Desired
• 3+ Years of Quality experience including Validation and Quality Engineering responsibilities.
• Excellent knowledge of the principles of Quality Engineering and Quality management as related to the validation process on medical devices.
• Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
• Six Sigma Certification Desired:
• ASQ CQE
• Working knowledge of 21CFR820, ISO 13485.