Key skills
Statistical AnalysisProject ManagementCommunicationProblem Solving
About this role
Role Overview
- Review test reports supporting Strategic Alliance customers integration acceptance testing
- Review non-product tool validation protocols and reports
- Assist with testing strategies and report formats
- Complete risk analysis
- Understand Hardware and Software Elements
- Handle Strategic Alliance Partner complaints and requests for Corrective Actions (SCARs)
- Drive root cause investigations and internal actions such as Corrective and Preventive Actions (CAPA), Product and Process Changes (CDPs)
- Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
- Review complain trends and provide input to Medtronic CQXM team from a strategic alliance customer standpoint
- Track of SCARs and reporting of SCAR metrics
- Specify inspection and testing mechanisms for material that is non-conforming
- Perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
- Drive for continuous improvement and updates to processes, templates and documents
- Respond to quality related questions from customers via the web portal or email sources
- Provide information on materials of concern
- Provide certificate of conformance
- Provide technical data to support strategic alliance partner regulatory submission
- Support Marketing with the PCN process and customer communication plan
- Assist Medtronic Regulatory Affairs and Quality related information and declarations
- Assist Medtronic Legal and Quality related input on Customer Agreements
- Oversee ISO compliance and testing related OEM products.
Requirements
- Bachelors degree required with 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience
- Project Management experience or training (nice to have)
- Experience working with customers
- Knowledge with Six Sigma or DRM
- Strong analytical and problem solving skills
- Excellent communication skills
- Ability to work effectively independently, within teams and across functions.
Benefits
- Competitive Salary
- Flexible Benefits Package