New · posted Oct 15
Midmark · Medical Devices
R+D Quality Engineer III
- Versailles, OH
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The R + D Quality Engineer III leads and enforces product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.
What you need
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications preferred.
COMPETENCY and/or SKILL
- Experience in the medical device industry and understanding of medical device quality systems and applications is desired.
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Strong written and verbal communication skills
- Ability to apply advanced analytical tools and methods to solve complex problems
- Ability to lead the design of complex systems and identify new technological opportunities
What you'll do
ESSENTIAL/PRIMARY DUTIES
- Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations.
- Leads all risk management processes and creates risk management documentation for (NPD) projects.
- Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.
- Facilitates the design and process failure mode and effects analysis (FMEA) process.
- Leads site-based quality department initiatives as a subject matter expert (SME).
- Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement.
- Collaborates with cross-functional teams to align decisions with business goals.
- Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies.
- Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.
SECONDARY DUTIES
- Supports internal and external quality system audits.
- Leads the creation of threat models and cybersecurity risk assessments.
- Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact.
- Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results.
SUPERVISORY RESPONSIBILITIES
- Provides leadership, coaching, and/or mentoring to level I and level II engineers.
Where you'll work
Versailles, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Versailles, OHJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Midmark's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Quality systems and risk6
- Lab testing and methods5
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Midmark on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Quality4 100%
By level
- Senior & Principal3 75%
- Associate & Specialist1 25%
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R+D Quality Engineer III at Midmark
Open until filled.