Salary
💰 $96,800 - $145,200 per year
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.
- 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