Senior Quality Engineering Manager

Role Overview

• Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way.
• Lead continuous improvement initiatives to strengthen technical rigor and simplify acquisition processes through enhancements to procedures, guidance, and tools, driving more efficient and effective integrations
• 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
• Advise/Coordinate with the OU’s to ensure a robust PAA is executed and a documented report is completed upon deal close
• 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
• 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.

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)