Senior Quality Engineer - Design Assurance

Danaher Corporation

Quick summary

Work type: On-site
Location: Cincinnati, OH
Salary: $100,000–$120,000 / yr
Posted: 108 days ago
Nearby: 49 roles within 25 mi

Market check

Salary context

Below market

How this pay compares to similar roles

Similar $167k

This role $110k

$89k most similar roles pay here $207k

This role pays less than 94% of similar roles. Most pay $138,187–$195,110 — the shaded band above. At the midpoint, this role pays about $110k versus about $167k for comparable roles.

Based on 240 similar postings.

Employer

About Danaher Corporation

Danaher Corporation is a leading global science and technology innovator focused on biotechnology, diagnostics, and life sciences.

Danaher Corporation currently has 26 open roles on FindRole.

Listed pay typically runs $116,000–$159,500 across 21 roles with salary data.

Most-posted roles

View all roles at Danaher Corporation

At a glance

TL;DR · Senior Quality Engineer - Design Assurance

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As a Senior Engineer in Quality Assurance at Mammotome, part of Danaher’s medical device division, you will support Design Control and Risk Management activities to ensure product compliance with international standards. Your day-to-day responsibilities include serving as the Design Quality Lead for new products, managing risk files, conducting usability studies, and supporting internal and external audits. You will also author updates to quality procedures and train employees on QMS elements. This role requires a bachelor’s degree in engineering, 5+ years of medical device industry experience, and expertise in ISO standards such as 13485 and 14971. Strong knowledge of design control principles and process validation is essential. You will work closely with cross-functional teams to maintain compliance within Mammotome’s Quality Management System, contributing to the development of innovative breast care solutions that improve patient outcomes.

Skills

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

What you'll do

Support Design Control and Risk Management activities to bring new products to market.
Independently maintain project risk management files using ISO 14971 principles.
Provide technical support for design control and risk management during audits.
Author updates to corporate quality procedures to ensure QMS compliance.
Assist in training employees on Quality and other QMS elements.

What we're looking for

Bachelor’s degree in engineering from an accredited college or university
Minimum 5 years of experience in medical device industry engineering roles
Comprehensive knowledge of international medical device quality systems regulations and standards
Strong application skills for design control principles in medical device development
Experience with process validation and manufacturing qualifications
Ability to travel up to 10% of the time, including overnight stays

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