New · posted Oct 29
Midmark · Medical Devices
R+D Quality Engineer II
- Versailles, OH
- On-site
- Full-time
- Senior & Principal
The role
The R + D Quality Engineer II leads 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 2+ years of relevant experience, or equivalent combination of both. Six Sigma Blackbelt (DMAIC, DMADV) Certification is preferred.
COMPETENCY and/or SKILL
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Strong written and verbal communication skills
- Advanced analytical skills, ability to define and analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
Skills named in this posting
What you'll do
ESSENTIAL/PRIMARY DUTIES
- 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.
- Assists with safety risk management processes and creation of 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.
- Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques.
- Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
- Mentors co-op and engineer I teammates, focusing on technical skills and cultural competencies.
- Expands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence.
SECONDARY DUTIES
- Supports internal and external quality system audits.
- Assists with the creation of threat models and cybersecurity risk assessments.
- Assists with 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.
SUPERVISORY RESPONSIBILITIES
- Provides leadership, coaching, and/or mentoring to co-op’s and level I 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 29, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Ohio5 roles publishing pay
Senior & Principal roles in the US325 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Ohio (middle half) | $80,000 | $81,000 | $92,500 |
| All US (middle half) | $104,000 | $123,000 | $142,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 975 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 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk5
- Collaboration and leadership5
- Lab testing and methods4
- 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
- 7
- Open roles
- 7
- Distinct roles
- 2
- Locations
By discipline
- Quality7 100%
By level
- Senior & Principal5 71%
- Manager1 14%
- Associate & Specialist1 14%
More roles at Midmark
- View role
R+D Quality Engineer III
Versailles, OHSenior & PrincipalMedical DevicesSalary not listed
- View role
Quality Engineer II
Versailles, OHSenior & PrincipalMedical DevicesSalary not listed
- View role
Quality Engineer I
Versailles, OHAssociate & SpecialistMedical DevicesSalary not listed
- View role
Senior Mechanical Design Engineer (Product Quality)
Versailles, OHSenior & PrincipalMedical DevicesSalary not listed
Similar Quality Assurance roles elsewhere
- View role
Quality Engineer II
The Cretex CompaniesBrooklyn Park, MNSenior & PrincipalMedical Devices$75K–$113K
- View role
Senior Supplier Quality Engineer – Supplier Development
PenumbraAlameda, CA · HybridSenior & PrincipalMedical Devices$119K–$166K
- View role
Sr Engineer Quality
MedlineChicago, IL +1 moreSenior & PrincipalMedical Devices$101K–$152K
- View role
Sr. Supplier Quality Engineer
Becton DickinsonMilpitas, CASenior & PrincipalMedical Devices$110K–$176K
R+D Quality Engineer II at Midmark
Open until filled.