Validation Engineer

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 while satisfying established embecta standards of quality. Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group. This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards. Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering / assurance principles.

RESPONSIBILITIES :

Essential functions include but are not limited to :

• 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 project 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.
• pplies 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. Make basic procedural updates.
• Demonstrates working knowledge of applicable regulatory, Corporate and / or Unit requirements.
• 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.
• pprove 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.

Essential functions include but are not limited to :

EXPERIENCE & EDUCATION :

EDUCATION

o B.S. degree in Engineering (Industrial, Mechanic) Desired

EXPERIENCE

KNOWLEDGE, SKILLS AND ABILITIES :