Quality Engineer II

Midmark Corporation; Versailles (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Midmark Corporation, located in Versailles, Ohio, is seeking a Quality Engineer to ensure product compliance with regulatory standards and drive quality improvements. Ideal candidates will have a bachelor's degree in engineering, 2+ years of experience, and preferably a Six Sigma Greenbelt certification. Responsibilities include maintaining the Quality Management System and applying engineering methods to solve problems.

The successful candidate will contribute to a collaborative environment and mentor junior engineers while working on regulatory compliance initiatives and quality assurance processes.

Qualifications

• 2+ years of relevant experience in engineering or related field.
• Experience with Six Sigma methods preferred.
• Ability to analyze complex problems and generate alternatives.

Responsibilities

• Ensure product compliance with regulatory agencies.
• Develop and improve the Quality Management System.
• Drive product quality improvements across teams.
• Conduct FMEA and participate in design control processes.

Skills

Engineering tools and methods

Microsoft Word

Microsoft Excel

Strong communication skills

Problem-solving skills

Education

Bachelor's degree in engineering or related field

Six Sigma Greenbelt certification

Tools

Minitab

Microsoft PowerPoint

Microsoft Project

Job description

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 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 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.

About Us

Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.

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