New · posted Oct 15
Midmark · Medical Devices
Quality Engineer I
- Versailles, OH
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Identifies, investigates, plans, and conducts activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.
What you need
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering or related field and 2+ years of relevant experience, or similar combination of both. Six Sigma Greenbelt certification is preferred.
COMPETENCY and/or SKILL
- Fully understand basic engineering tools and methods
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Strong written and verbal communication skills
- Ability to contribute ideas for process changes and improvements
- Ability to define and analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
What you'll do
ESSENTIAL/PRIMARY DUTIES
- Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
- Assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
- Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
- Identifies testing and validation opportunities, contributes to product and process improvements.
- Works on moderately complex projects, generates alternatives, and conducts testing.
- Applies new tools and identifies opportunities for improvements using six sigma methods.
- Conducts the design and process failure mode and effects analysis (FMEA) process.
- Participates in Design Control Process (including design input, design output, reviews, qualifications, validations, etc.).
- Identifies and communicates risks, participates in issue resolution, mentors junior engineers.
- Applies advanced engineering methods and tools to solve engineering problems.
SECONDARY DUTIES
- Provides leadership, coaching, and/or mentoring to the co-op group and level I engineers.
- Supports internal and external QMS audits and/or investigations.
- Understands engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.
- Follows industry standards and regulations for quality, safety, and performance.
SUPERVISORY RESPONSIBILITIES
- Provides leadership, coaching, and/or mentoring to level I engineers and co-op's.
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
Associate & Specialist roles in Ohio6 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Ohio (middle half) | $53,000 | $66,250 | $79,500 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
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 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods6
- Collaboration and leadership5
- GMP and compliance4
- Quality systems and risk3
- Investigations and CAPA2
- Validation and qualification2
- Documentation and SOPs1
- 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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Quality Engineer I at Midmark
Open until filled.