Senior Quality Engineering Manager

About the role

The Senior Quality Engineering Manager will play a critical role in supporting Operating Units (OU) throughout the acquisition lifecycle, including due diligence, post-acquisition assessments, and integration planning and execution.

Responsibilities

• Perform patient safety and technical assessments of acquisition targets during the Due Diligence and Post-Acquisition Assessment periods per procedure 042-P026, to identify quality system, product, process, design control, and risk management gaps that may impact patient safety, regulatory compliance, product performance, or successful integration.
• Lead the quality functions on how to create a cost model to support integration and remediation upon acquisition of a target acquisition.
• Support 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
• 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.

Requirements

• Minimum 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 years of work experience in Quality and/or experience in a regulated industry plus 5 years of leadership experience
• Key Skills & Experience: Strong knowledge in 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, Excellent stakeholder management and communication skills, 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.

Qualifications

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Skills

• 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)

Benefits

At Medtronic, we offer a competitive Salary and flexible Benefits Package. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Pay

$171,200.00 - $256,800.00

Schedule

Minimum of 4 days a week onsite