Medtronic

Senior Customer Quality Engineer

Medtronic

full-time

Posted on:

Location Type: Hybrid

Location: Lafayette • Colorado • 🇺🇸 United States

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Salary

💰 $96,800 - $145,200 per year

Job Level

Senior

About the role

  • Manage a variety of quality activities related to the Acute Care & Monitoring Strategic Alliance customers
  • Work closely with the R&D group on integration acceptance testing and root cause investigations
  • Ensure quality controls are in place with manufacturing sites
  • Communicate with customers concerning quality issues and drive for resolution and continuous improvement
  • Respond to ongoing customers’ requests and inquiries
  • Work closely with the Marketing team to address any customer quality needs
  • Review test reports supporting Strategic Alliance customers integration acceptance testing
  • Review non-product tool validation protocols and reports
  • Complete risk analysis
  • 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)
  • Ensure corrective measures meet acceptable reliability standards and documentation is compliant
  • 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 materials
  • Perform statistical analysis to assess costs for non-compliant products
  • Drive continuous improvement and updates to processes, templates, and documents
  • Respond to Quality related questions from Customers via the web Portal or E-mail 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 with quality related information
  • Assist Medtronic Legal with quality related input on Customer Agreements
  • Oversee ISO compliance and testing related to OEM products.

Requirements

  • Minimum of 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
  • Excellent communication skills
  • Ability to work effectively independently, within teams, and across functions.
Benefits
  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Applicant Tracking System Keywords

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

Hard skills
integration acceptance testingroot cause analysisrisk analysisCorrective and Preventive Actions (CAPA)statistical analysisISO compliancenon-product tool validationquality controlscomplaint trend analysisinspection and testing mechanisms
Soft skills
analytical skillsproblem-solving skillscommunication skillsindependent workteam collaborationcross-functional collaborationcustomer servicecontinuous improvement mindsetresolution drivingcustomer inquiry response
Certifications
Project Management certificationSix Sigma certificationDRM training
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