What are the responsibilities and job description for the Site Validation / Quality Engineer position at MRCC?
Role 1 ) Site Validation
Essential functions include but are not limited to :
Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
Develop and maintain the Validation Master Plan and validation tracking schedule.
Provide visibility related to all validation activities through tracking and reporting plant metrics.
Support and influence change management within the plant : liaison between the core team, program managers, and Global quality.
Conduct training relevant to validation process and procedures.
Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
Participate in Global validation team meetings as required.
Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Build interactive working and strategic relationships between company Holdrege manufacturing, business and corporate quality management and other staff.
Perform other duties as assigned by the Team Leader and required to support the needs of the business.
Role 2 ) Quality Engineer II
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 Project Pear 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.
Make basic procedural updates.
Demonstrates working knowledge of applicable regulatory, Corporate and / or Unit requirements.
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.
Approve 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.
Basic 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 medical devices.
Strong understanding of failure analysis, test methods and engineering tolerances.
Preferred Requirements :
Strong verbal, written and interpersonal skills.
Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
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