As a Senior Quality Engineer at Medtronic’s Surgical Innovations group in North Haven, CT, you will play a crucial role in maintaining high standards of quality and compliance within the Surgical Sutures’ Manufacturing business. Your responsibilities include developing and implementing quality protocols, collaborating with engineering and manufacturing teams to ensure regulatory adherence, and conducting statistical analyses for continuous improvement. You will specialize in areas such as process validation, root cause analysis, and nonconforming material management, using tools like Minitab to drive data-driven decisions. This role requires a Bachelor’s degree in Engineering or Science, preferably with experience in FDA-regulated manufacturing environments, and expertise in end-to-end medical device processes including chemical processing and sterilization.
Skills
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
What you'll do
Develop and modify quality standards and protocols for manufacturing processes.
Design inspection methods and equipment to ensure product accuracy and reliability.
Conduct quality assurance tests and perform statistical analysis on products.
Ensure corrective measures meet acceptable reliability and documentation standards.
Specialize in areas such as design, production control, or research and development.
What we're looking for
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of relevant experience.
Develop and maintain quality standards and protocols for manufacturing processes.
Collaborate cross-functionally to enhance product reliability and optimize processes.
Specialize in process validation across the full lifecycle in regulated environments.
Lead root cause investigations, CAPA development, and manage nonconforming material activities.
Proficient in statistical analysis tools (e.g., Minitab) for data-driven decision making.
Market check
Salary context
This
$98,400–$147,600
range sits above
6%
of similar postings on FindRole.
Peer median band
$117,000–$199,400
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$135,802–$184,600
Middle half of comparable postings.
Based on 240 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.
Usa-Mn Mounds View Central, US14 days ago
$171,200–$256,800
FMEA
CAPA
ISO13485
FDA
CE Marking
Risk Management
Design Controls
Root Cause Analysis
Quality Management Systems
Regulatory Compliance
Post Market Surveillance
KPIs
Change Management
Continuous Improvement
Lean Six Sigma
Usa - Cincinnati - Devicor Medical Products, Inc. - Cincinnati Hq, US98 days ago
$100,000–$120,000
ISO
FDA
MDSAP
21 CFR 820
ISO 13485
ISO 14971
Design Control
Risk Management
Process Validation
Manufacturing Qualifications
Quality Management System
Six Sigma
Certified Quality Engineer