Senior Quality Engineering Manager (Medtech)

TL;DR

Senior Quality Engineering Manager (Medtech): Leading quality functions within the Acquisition & Integration Center of Expertise with an accent on due diligence, post-acquisition assessments, and integration planning. Focus on ensuring regulatory compliance, patient safety, and design control integrity during organizational growth and transformation.

Location: Must be based in Mounds View, Minnesota, USA. Role requires onsite presence at least 4 days per week.

Salary: $171,200 – $256,800 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Perform patient safety and technical assessments of acquisition targets during due diligence.
• Lead quality functions to create cost models for integration and remediation.
• Develop and execute risk-based integration plans covering QMS, IT, and CAPA activities.
• Track high-risk key process indicators to drive patient safety and compliance.
• Build collaborative relationships with cross-functional stakeholders to ensure effective integration.
• Coordinate with multidisciplinary teams across various time zones to support global initiatives.

Requirements

• Bachelor’s degree with 7 years of experience in Quality or a regulated industry, plus 5 years of leadership experience.
• Advanced degree with 5 years of experience in Quality or a regulated industry, plus 5 years of leadership experience.
• Strong knowledge of Design Controls, Manufacturing Quality, and Supplier Quality.
• Expertise in global regulations and standards such as ISO 13485 and ISO 14971.
• Proven ability to influence cross-functional, multi-site, and geographically diverse partnerships.
• Must possess unrestricted U.S. work authorization at the time of hire.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and short-term incentive plans.
• Commitment to professional growth and cross-functional collaboration.