More jobs:
Quality Engineer II
Job in
Versailles, Darke County, Ohio, 45380, USA
Listed on 2026-06-01
Listing for:
Midmark
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
JOB SUMMARY:
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.
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.
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
SUPERVISORY RESPONSIBILITIES:
* Provides leadership, coaching, and/or mentoring to level I engineers and co-op's.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×