Quality Engineer II

Medtronic

Remote Actively hiring
North Haven, CT · Remote, USA Posted 16 days ago $79,200–$118,800 / year
View original post Log in to save

At a glance

AI generated

TL;DR

As a Quality Engineer II on Medtronic’s Advanced Surgical Instruments team in North Haven, CT, you will support the Access, Instrumentation, and Powered Focus Factory by ensuring that surgical instruments meet stringent quality standards. Your day-to-day responsibilities include providing floor support to resolve immediate quality issues, collaborating with cross-functional teams to maintain compliance with regulatory requirements, leading root cause investigations and CAPA activities, and developing inspection methods for product quality assurance. You will utilize statistical tools like Minitab for data analysis and continuous improvement initiatives, fostering a culture of excellence in patient safety and operational reliability within the advanced manufacturing environment. This role requires a Bachelor’s Degree in Engineering or Science with 2+ years of relevant experience or an Advanced Degree. Ideal candidates have experience in regulated manufacturing settings, process validation, and Six Sigma methodologies.

Skills

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

What you'll do

  • Monitor and support manufacturing processes to ensure adherence to quality standards.
  • Lead investigations into nonconformances and implement Corrective and Preventive Actions (CAPA).
  • Develop and maintain inspection methods for product quality assurance.
  • Use statistical tools to analyze process performance and drive defect reduction.
  • Coach operators and engineers on compliance with quality system requirements.
  • Prepare for and participate in internal and external audits related to regulatory standards.

What we're looking for

  • Bachelor’s Degree in Engineering, Science or technical field with 2+ years of relevant experience.
  • Lead root cause investigations and Corrective and Preventive Actions (CAPA).
  • Develop and maintain inspection and testing methods for product quality assurance.
  • Utilize statistical methods and data analysis to monitor process performance and drive continuous improvement.
  • Apply knowledge of ISO 13485, FDA QSR, and other regulatory standards in a manufacturing environment.

Market check

Salary context

This $79,200–$118,800 range sits above 3% of similar postings on FindRole.

Peer median band

$116,600–$189,320

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$124,000–$182,801

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.

Most-posted roles

View all roles at Medtronic

More like this

Similar roles

Quality Engineer II

Medtronic

Remote (Usa-Pr Humacao, US) 10 days ago
Process Validation Risk-Based Validation Machine Complete Equipment Qualification FMEA Risk Management Tools Statistical Methods SPC DOE 5 Why Fishbone DMAIC Minitab Python VBA Lean Six Sigma GMP FDA Quality System Regulation ISO 13485
Remote

Senior Quality Engineer

Medtronic

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
Remote

Service and Repair (S&R) Engineering Quality Director

Medtronic

Remote (Usa-Mn Rice Creek West, US) 16 days ago $198,400–$297,600
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
Remote

Senior Supplier Quality Engineer

Medtronic

Remote (Usa-Nc, US) 10 days ago $99,200–$148,800
ISO FDA Quality System Regulation ISO 13485 ISO 14971 DOE MSA SPC Lean Six Sigma CI/CD GMP 21 CFR Part 820 Supplier Change Request (SCR) processes
Remote

Quality Engineer 4

Lam Research

Tualatin, Or,Us, US 15 days ago
PowerBI QMS ISO 9001 Lean Six Sigma DMAIC 8D PSDMP CI/CD TQM Six Sigma Minitab Excel Word Visio Project Management Process Mapping Manufacturing Engineering Quality Analytics Root Cause Analysis Corrective Action

Associate Quality Engineer

Q2

Austin, Texas, US 28 days ago
Selenium Python CI/CD Git JIRA Agile RESTful APIs SQL Terraform AWS Kubernetes Docker PostgreSQL Grafana Prometheus GitHub Copilot Codex Claude Code