Quality Engineer I

Regulatory Jobs; Versailles (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Regulatory Jobs is seeking a quality engineer to identify, investigate, plan, and conduct activities to improve quality in the design and manufacturing of medical devices and components.

You will collaborate cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, regulatory compliance, and cost. Bachelor's degree in engineering and 2+ years of related experience are required; Six Sigma Green Belt is preferred.

Qualifications

• Bachelor's degree in engineering or related field and 2+ years relevant experience.
• Six Sigma Green Belt certification preferred.

Responsibilities

• Ensures products and changes comply with FDA, ISO, UL, CSA, etc.
• Develops, maintains, and improves the QMS for regulatory compliance.
• Drives product quality improvements with design, manufacturing, and supply chain.
• Identifies testing and validation opportunities and contributes to improvements.
• Works on moderately complex projects, generates alternatives, and conducts testing.
• Applies Six Sigma methods to identify opportunities for improvements.
• Conducts the design and process FMEA process.
• Participates in Design Control Process (design input/output, reviews, validations).
• Identifies risks, communicates them, and mentors junior engineers.
• Applies advanced engineering methods and tools to solve problems.

Skills

Engineering problem solving

Communication

Process improvement

Education

Bachelor's degree in engineering or related field

Six Sigma Green Belt certification

Tools

Microsoft Word

PowerPoint

Excel

MS Project

Minitab

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/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.