Join Medtronic as a Service & Repair (S&R) Engineering Quality Director to lead quality and operational excellence in a multi-site, cross-functional organization. Reporting to the VP of Global Quality Excellence | Global Quality, you will set strategy and drive execution for QMS processes supporting repair, refurbishment, and service operations, ensuring compliance with ISO 13485 and FDA regulations. You will mentor an engineering team, oversee quality engineering for post-market support, root cause analysis, corrective actions, audits, and supplier quality, and collaborate with commercial teams to align service strategies with business goals. This role requires a bachelor’s degree in Engineering and at least 10 years of experience in Operations and Quality within a regulated environment, plus 7+ years of managerial experience. Ideal candidates have medical device industry experience, CAPA management expertise, and Lean/Continuous Improvement certifications.
Skills
ISO13485
FDA 21 CFR Part 820
CAPA management
Good Manufacturing Practices (GMP)
Good Documentation Practices (GDP)
Quality Management System (QMS)
Lean
Continuous Improvement
5S
MPS
Medtronic Performance System
What you'll do
Lead and execute Quality Management System (QMS) processes for repair and service operations.
Ensure compliance with ISO 13485 and FDA regulations for serviced medical devices.
Oversee quality engineering of post-market support, root cause analysis, and corrective actions.
Develop and maintain QMS compliant to ISO standards and FDA regulations for S&R operations.
Manage a global team responsible for Service & Repair Quality support across multiple sites.
What we're looking for
Bachelor’s degree in Engineering with 10+ years of combined relevant experience in Operations and Quality within ISO13485/FDA environments.
Advanced degree with 8+ years of combined relevant experience in Operations and Quality within ISO13485/FDA environments.
Minimum 7+ years of managerial experience leading quality engineering teams.
Experience developing and maintaining QMS compliant to ISO standards and FDA regulations.
Proven ability to lead cross-functional, multi-site initiatives for continuous improvement.
Expertise in CAPA management, GMP, GDP, and QMS leadership within regulated environments.
Demonstrated success in driving organizational change resulting in measurable SQDC performance improvements.
Market check
Salary context
This
$198,400–$297,600
range sits above
85%
of similar postings on FindRole.
Peer median band
$125,680–$208,600
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$137,918–$216,300
Middle half of comparable postings.
Based on 238 comparable postings.*
* 240 is the maximum number of comparable postings sampled.
Employer
About Medtronic
Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.
Medtronic currently has
24 open roles
on FindRole.
Listed pay typically runs
$135,200–$198,000
across 24 roles with salary data.
Remote (Usa-Ct North Haven, US)16 days ago
$79,200–$118,800
SPC
Minitab
ISO 13485
FDA QSR
Six Sigma
CAPA
Process Validation
IQ
OQ
TMV
PQ
Statistical Methods
Trend Analysis
Sampling Plans
Kanban
Lean Manufacturing
Continuous Improvement
Data Analysis