Hardware Quality Engineer
Red 6
ERP
Senior Customer Quality Engineer
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • Colorado
Visit company websiteSalary
💰 $96,800 - $145,200 per year
Job Level
Senior
About the role
- Manage quality activities related to Acute Care & Monitoring Strategic Alliance customers
- Partner with OEM customers and Strategic Alliance Partners to ensure quality, reliability, and safety
- Work closely with R&D on integration acceptance testing and root cause investigations
- Work with manufacturing sites to ensure quality controls are in place
- Communicate with customers concerning quality issues and drive for resolution and continuous improvement
- Respond to customers’ requests and inquiries and work closely with Marketing to address customer quality needs
- Review test reports supporting Strategic Alliance customers integration acceptance testing
- Review non-product tool validation protocols and reports and assist with testing strategies and report formats
- Complete risk analysis and 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 CAPA and Product and Process Changes (CDPs)
- Ensure corrective measures meet reliability standards and documentation compliance
- Review complaint trends and provide input to Medtronic CQXM team from a Strategic Alliance customer standpoint
- Track SCARs and report SCAR metrics
- Specify inspection and testing mechanisms for non-conforming material
- Perform statistical analysis to assess cost and responsibility for non-conforming products/materials
- Drive continuous improvement and updates to processes, templates and documents
- Respond to Quality related questions from Customers via the web Portal or E-mail
- Provide information on Materials of Concern and Certificates of Conformance
- Provide technical data to support Strategic Alliance Partner regulatory submission
- Support Marketing with PCN process and customer communication plan
- Assist Regulatory Affairs and Legal with Quality related information and input
- Oversee ISO compliance and testing related to OEM products and provide input to R&D testing
Requirements
- Bachelor’s degree required
- Minimum of 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 (nice to have)
- Knowledge with Six Sigma or DRM (nice to have)
- Strong analytical and problem-solving skills
- Excellent communication skills
- Ability to work effectively independently, within teams, and across functions
- Ability to interact with computer and communicate with peers and co-workers (physical job requirements)
