This role pays less than
82%
of similar roles. Most pay
$131,656–$182,706
— the shaded band above.
At the midpoint, this role pays about
$123k
versus about
$157k
for comparable roles.
Based on 240 similar postings.
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
47 open roles
on FindRole.
Listed pay typically runs
$110,400–$165,600
across 45 roles with salary data.
Sr Quality Engineer
The Sr Quality Engineer joins the surgical operating unit within the new product development quality team to ensure patient safety is embedded throughout the medical device lifecycle. This role involves developing and maintaining comprehensive risk management strategies, including creating risk management files, performing hazard and risk analysis, and leading Design Failure Modes and Effects Analyses (DFMEAs). The position also requires managing post-market surveillance plans, conducting root cause analyses for field issues, and ensuring traceability between requirements and design outputs using a requirements management tool. Candidates must possess expertise in FDA regulations, ISO 13485, ISO 14971, and ISO 62304 standards. Essential skills include proficiency in quality management systems, risk management, regulatory compliance, and statistics. The role addresses the critical challenge of ensuring medical device safety and regulatory compliance during the development of innovative surgical technologies.
ISO 13485
21 CFR 820
GMP
NPI
FMEA
IQ/OQ/PQ
Verification and Validation
Risk Management
Change Control
Quality Management System
Design Control
Process Qualification
Equipment Qualification
Risk Management
ISO 13485
ISO 14971
DFMEA
Root Cause Analysis
Design Controls
Quality Management Systems
Requirements Management
Post-Market Surveillance
Six Sigma
Project Management
QMS
CAPA
ISO 13485
FDA QSR
Six Sigma
Lean
DMAIC
Minitab
Python
VBA
Root Cause Analysis
FMEA
MES
Data Analytics
Statistical Analysis
Validation
Risk Management
ISO 13485
FDA Quality System
CAPA
Root Cause Analysis
Risk Management
Process Validation
Six Sigma
Change Control
Nonconforming Product Control
Quality Engineering
Product Reliability
Continuous Improvement
Lean Manufacturing
Six Sigma
IQ/OQ/PQ
FDA
GMP
ISO 13485
CAPA
Root Cause Analysis
SPC
FMEA
DOE
Process Optimization
Automation
Project Management
Manufacturing Engineering