Quality Engineer I

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.