Medline Industries, LP is looking to ensure regulatory compliance and product quality by planning and executing verification and validation activities for their products.
Requirements
- At least 2 years with verification or validation testing.
- Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
- Experience evaluating information to determine compliance with standards, laws, and regulations.
- Assist with test method development activities including test fixture design, equipment acquisition, and hardware/software validation.
Responsibilities
- Test and evaluate new and existing products of moderate to advanced complexity.
- Interpret data and evaluate product performance to verify product requirements and design inputs.
- Execute and assist with the development of verification and validation protocols.
- Issue reports for regulatory audits, submissions and requests.
- Create accurate and thorough documentation that records all steps taken and all measurements used through the verification and validation lifecycle.
- Analyze test results and contribute to design and failure investigations.
- Determine the root cause of defects, safety risks, and performance problems.
Other
- Manage assigned projects, establish appropriate timelines, and ensure that deadlines/project goals are met.
- Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
- Ensure regulatory compliance by inspecting, measuring, analyzing, auditing, calibrating and testing instrumentation, equipment, software/hardware, machines and/or procedures.
- Identify problems and their sources and correct them quickly and efficiently.
- Implement process improvement initiatives and identify product improvement opportunities.