Medtronic

Senior Quality Engineer

Medtronic

full-time

Posted on:

Location Type: Hybrid

Location: Galway • Ireland

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Salary

💰 €62,320 - €93,480 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
risk analysisstatistical analysistesting strategiescorrective and preventive actions (CAPA)product and process changes (CDPs)inspection mechanismsdocumentation compliancequality managementISO complianceregulatory submission
Soft Skills
analytical skillsproblem solvingcustomer communicationteam collaborationindependent workcontinuous improvementinterpersonal skillsorganizational skillsleadershipadaptability
Certifications
Bachelor's degreeadvanced degreeProject Management certificationSix Sigma certificationDRM training