QA Automation Engineer II at INVID ensuring software quality through automated testing and collaboration. Working in a hybrid environment from San Juan, PR within the Operations department.
About the role
- Senior Quality Engineer collaborating with OEM customers to ensure quality and reliability in medical devices. Leading investigations and driving process improvements in quality management.
Responsibilities
- 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 complaint trends and provide input to Medtronic CQXM (Customer Quality Experience Management) team from a strategic alliance customer standpoint.
- Track SCARs and reporting of SCAR metrics.
- Specify inspection and testing mechanisms for material that is non-conforming.
- Perform statistical analysis to assess the cost 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 (Product Change Notification) 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.
- Experience working with customers.
- Knowledge with Six Sigma or DRM.
- Strong analytical and problem solving skills.
- Ability to work effectively independently, within teams and across functions.
Benefits
- Competitive Salary
- Flexible Benefits Package
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