As a Principal Supplier Quality Engineer at Medtronic, you will lead the management and oversight of strategic Contract Manufacturers and OEMs, ensuring that supplied products meet stringent quality standards. Your day-to-day responsibilities include qualifying suppliers, monitoring parts through manufacturing cycles, developing auditing schedules, and providing technical guidance throughout new product development. You will collaborate closely with internal teams such as R&D, Quality, and Regulatory to maintain compliance with industry regulations like FDA 21 CFR Part 820 and ISO standards. Ideal candidates possess advanced knowledge of medical device regulations, experience in supplier audits, and a background in continuous improvement methodologies like Lean or Six Sigma. This remote role requires occasional travel for enhanced collaboration and project success.
Skills
ISO
FDA 21 CFR Part 820
ISO 13485
ISO 14971
Lean
Six Sigma
PPAP
MSA
PFMEA
CAPA
GMP
Quality Engineering
Supplier Audits
Receiving Inspection
Control Plans
Product Acceptance Sampling Strategy
Approved Supplier List
What you'll do
Ensure suppliers deliver quality parts, materials, and services according to company standards.
Develop and prioritize auditing schedules to maintain good manufacturing practices and quality standards.
Evaluate supplier internal functions to assess performance and provide feedback on operations.
Provide technical guidance and ensure compliance with industry standards, regulatory requirements, and customer needs.
Collaborate with engineering teams to develop product acceptance sampling strategies and control plans for new products.
What we're looking for
Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality.
Advanced knowledge of medical device regulations such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and global regulatory expectations.
Experience supporting external contract manufacturers for finished medical devices, including oversight of supplier quality agreements and performance monitoring.
Demonstrated ability to lead complex supplier investigations, root cause analysis, CAPA development, and implementation of corrective actions across multi-site supply chains.
Certification or formal training in continuous improvement methodologies such as Lean, Six Sigma (Green Belt or higher), FTQ, or similar process improvement frameworks.
Market check
Salary context
This
$123,200–$184,800
range sits above
36%
of similar postings on FindRole.
Peer median band
$130,100–$208,700
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$139,550–$205,000
Middle half of comparable postings.
Based on 239 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
Remote (Usa-Ct North Haven, US)14 days ago
$98,400–$147,600
Minitab
FDA CFR requirements
ISO 13485
Six Sigma
Lean Manufacturing
GMP
CAPA
NCMR
Root Cause Analysis
Statistical Process Control
Process Validation
Machining
Chemical Processing
Packaging
Sterilization
Engineering Drawings
CI/CD