Senior Quality Engineer

Medtronic

Confirmed live today High trust

Closes in 5 days

Quick summary

Work type: On-site
Location: Humacao, Puerto Rico
Employment: Full-time
Posted: 3 days ago
Freshness: Confirmed live today
Closes: Oct 2, 2026 (soon)
Nearby: 3 roles within 25 mi

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Salary context

How this pay compares to similar roles

Similar $157k

$118k most similar roles pay here $198k

This listing doesn't post a salary. Most similar roles pay $134,302–$180,500.

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 77 open roles on FindRole.

Listed pay typically runs $124,000–$186,000 across 73 roles with salary data.

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At a glance

TL;DR · Senior Quality Engineer

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The Sr Quality Engineer provides quality engineering leadership for machining and secondary operations, including anodizing and final pack. Working within a cross-functional team, the individual ensures product and process quality by confirming that manufacturing processes, equipment, components, and documentation meet regulatory requirements and internal management systems. Key responsibilities include developing inspection methods, performing statistical analysis to evaluate process capability, managing nonconformance and CAPA activities, and ensuring audit readiness for GMP, FDA, and ISO standards. The role requires expertise in medical device manufacturing, risk assessment tools like FMEA and Fishbone, and technical writing for investigation reports. Candidates should be proficient with Minitab, JMP, Excel, Power BI, or SAP. This position solves critical quality risks in the production of medical devices by ensuring that all materials and processes meet strict safety and performance specifications.

Skills

GMP ISO 13485 FDA CAPA Lean Six Sigma SPC DOE Minitab JMP Excel Power BI SAP JDE Factory Works VBA Python Copilot ChatGPT Gemini IQ OQ PQ

What you'll do

Provide quality engineering leadership for machining, anodizing, and final pack manufacturing processes.
Ensure all products, equipment, and documentation comply with GMP, FDA, and ISO regulatory requirements.
Develop and implement inspection, testing, validation, and process evaluation methods for production components.
Perform statistical analysis to evaluate process capability and investigate nonconforming materials or products.
Manage nonconformance reports (NCR) and Corrective and Preventive Actions (CAPA) to ensure product safety.
Conduct risk assessments and root cause analyses using tools like FMEA and Fishbone diagrams.
Author technical documentation, including validation protocols, investigation reports, and change control justifications.
Partner with cross-functional teams to establish and maintain quality controls for new product launches.

What we're looking for

A Bachelor's degree in engineering is required, or a Master's with 2 years of experience, or a PhD.
Candidates must have at least 4 years of relevant experience if holding a Bachelor's degree.
Experience in regulated manufacturing environments such as medical devices or pharmaceuticals is preferred.
Practical knowledge of ISO 13485, FDA Quality System Regulations, and GMP requirements is preferred.
Proficiency in quality systems including CAPA, change control, nonconformance management, and risk assessment is preferred.
Experience with validation concepts (URS, IQ, OQ, PQ) and statistical tools like SPC or DOE is preferred.
Lean Six Sigma Green Belt or Black Belt certification is preferred.
Work authorization at the time of hire and for the duration of employment.

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