Quality Engineer II

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.