Senior Quality Engineering Manager
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Mounds View • Colorado • Connecticut • United States
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Salary
💰 $168,800 - $253,200 per year
Job Level
About the role
- Assess and identify gaps from a “Patient Safety” and “Technical” insight within a potential target acquisition
- Lead OU’s on how to create a cost model $ to support integration and remediation upon acquisition of a target acquisition
- Lead OU’s with respect to executing the required quality leadership tiered reviews prior to deal close
- Advise/Coordinate with the OU’s to ensure a robust PAA is executed and a documented report is completed upon deal close
- Assess potential patient safety concerns using the Health Hazard Assessment process
- Identify Subject Matter Experts to support OU’s where additional technical expertise is required
- Develop a risk and time-based integration plan with the OU’s that covers: CAPA’s addressing PAA findings QMS and IT Integration Remediation Activities
- Establish and track high risk key process indications that drive patient safety, technical and compliance risk reduction
- Develops collaborative working relationships with other functions through effective communication and interaction, ensuring OU’s understand the necessary minimum requirements to support integration closure
- Support internal quality assessments that confirm the robustness of integration activities executed
- Lead procedural and continuous process improvements through collection of VOC and Lessons Learned
- Eliminate waste through the automation of the acquisition and integration execution tools
Requirements
- Bachelor’s degree with 7 years of work experience in Quality and/or experience in a regulated industry plus 5 years of leadership experience OR advanced degree with 5 of work experience in Quality and/or experience in a regulated industry plus 5 years of leadership experience
- Strong knowledge of design controls, supplier quality, manufacturing quality, and applicable global regulations and standards (e.g., FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971)
- Demonstrated ability to build and influence cross‑functional, multi‑site, and geographically diverse partnerships, balancing divergent objectives to achieve alignment on program goals and execution plans
- Excellent stakeholder management and communication skills, with a proven ability to lead meetings and effectively engage internal teams, external customers, and vendors
- Proven track record of establishing, improving, and optimizing processes and systems to drive efficiency and operational effectiveness
- Strategic leader and thinker who can balance long‑term vision with practical, execution‑focused decision making
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 & Tools
quality leadershiprisk assessmentcost modelingCAPAHealth Hazard Assessmentprocess improvementautomationdesign controlssupplier qualitymanufacturing quality
Soft Skills
stakeholder managementcommunicationcollaborationinfluenceleadershipstrategic thinkingcross-functional partnershipproblem-solvingengagementdecision making