Perform patient safety and technical assessments of acquisition targets during the Due Diligence and Post-Acquisition Assessment periods to identify quality system, product, process, design control, and risk management gaps that may impact patient safety, regulatory compliance, product performance, or successful integration.
Leads the quality functions on how to create a cost model to support integration and remediation upon acquisition of a target acquisition.
Supports quality partners to develop and execute a risk and time-based integration plan that covers: CAPA’s addressing compliance findings, QMS and IT Integration, Remediation Activities.
Establish and track high risk key process indications that drive patient safety, technical and compliance risk reduction.
Builds collaborative relationships with cross-functional stakeholders, ensuring all teams have the information and resources needed for effective integration.
Coordinates and collaborates remotely with multidisciplinary teams across various time zones and geographies to support global acquisition initiatives.

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 in one and/or all of the following areas: Design Controls, Manufacturing Quality, Supplier Quality, Global Regulations and Standards (e.g., 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.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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)

Senior Quality Engineering Manager

Key skills