Test Validation Engineer Manufacturing Engineer -Medical

Title : Test Validation Engineer Medical

Job id : 483551

Location : West Columbia South Carolina (Onsite)

Duration : Contract

Job Description:

The Test Validation Engineer demonstrates leadership in communicating developing and executing program schedules process developments and analysis in various organizational settings regarding internal and external business goals. In this role you will utilize your experience and expertise to solve problems develop & execute objectives & have the ability to meet company objectives within the time lines specifically related to your assigned projects.

Essential Responsibilities:

• Provide support to the engineering manufacturing logistics and quality functions within a team participation setting regarding Equipment Validation Activities.
• Document and communicate the results of problem solutions and conduct analytical examinations to both internal and external customers.
• Update and develop validation documents where required.
• Lead Validation activities associated with assigned projects.
• Coordinate and facilitate process improvements and implement controls per assigned projects.
• Coordinate with staff program managers on timing and executions of validations per assigned projects.

Qualifications/Requirements:

• B.S in Engineering or Technical Practice
• Minimum of 5 years of experience in an engineering or quality related position.
• Experience with Medical Industry Standards submittals and execution.
• Support the Validation team with all necessary quality and validation functions to assigned equipment
• Support the development and execution of master validation plans
• Preparation of the DOE Matrix and executing the process as per the matrix.
• Information analysis and Optimizing the critical parameter as per the inspection report
• Perform the process optimization runs
• Process dev/engg. study report preparation and approval follow up
• Develop IQ/ OQ / PQ protocols approval follow up execution and monitoring performance
• Conduct document reviews where requested and coordinate corrective actions to resolve

Desired Characteristics:

• Strong oral and written communication skills
• FDA 21 CFR 820198 experience. 21CFR Part 11 21CFCR and ISO13485 regulations
• Capability to work in teams
• Six Sigma Green Belt Certified.
• QMS implementation experience.
• Manufacturing Experience with Medical Industry Components.

Keywords to search: Medical Validation Eng IQOQPQ CFR21 ISO 14971 ISO 13485 Assembly Manufacturing Engineer