Quality Engineer II

Medtronic

Remote Actively hiring Verified listing

Remote, USA · Usa-Pr Humacao, US Posted 10 days ago

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At a glance

AI generated

TL;DR

As a Quality Engineer II in New Product Introduction at Medtronic, you will ensure product and process quality throughout development, validation, and production readiness. Your daily tasks include leading risk-based validation activities, confirming equipment and process readiness for production release, and supporting nonconformance and CAPA activities. You’ll collaborate closely with cross-functional teams to drive compliance with GMP, FDA, and ISO requirements through disciplined documentation and audit readiness. Key skills required are strong knowledge of Process Validation (IQ/OQ/PQ), risk management tools like FMEA, statistical methods such as SPC, and root cause investigation techniques. Experience in regulated manufacturing environments is preferred, along with a Bachelor’s or Master’s degree in Engineering.

Skills

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

What you'll do

Leads and supports risk-based validation activities including IQ/OQ/PQ.
Confirms process and equipment readiness for production release.
Ensures effective component qualification, change control, and lifecycle support.
Drives compliance with GMP, FDA, ISO requirements through disciplined documentation.
Analyzes data to identify quality risks and supports nonconformance/CAPA activities.

What we're looking for

Requires Baccalaureate degree and 2+ years of relevant experience or Master's degree.
Strong knowledge of Process Validation (IQ/OQ/PQ) and risk-based validation approaches.
Experience with machine complete/equipment qualification and production readiness.
Proficiency in risk management tools such as FMEA, hazard analysis, and risk assessments.
Knowledge of statistical methods including SPC, capability analysis, and DOE.
Expertise in root cause investigation tools like 5 Why, Fishbone, DMAIC.

Market check

Salary context

This listing doesn't show a salary. Similar roles on FindRole typically pay $116,600–$189,320.

Peer median band

$116,600–$189,320

Median floor and ceiling across peers.

Typical midpoint (25–75%)

$123,966–$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.

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