Engineer II, Quality

About the Role

The Manufacturing Quality Engineer (QE) provides oversight and guidance to manufacturing operations by ensuring compliance to industry standards and quality system regulations. The QE coaches manufacturing and cross-functional personnel on proper cGMP requirements to ensure high-quality product manufacturing. This role uses Quality Engineering Principles and Continuous Improvement Tools to drive systemic improvements in Manufacturing Operations and Quality Systems, ensuring compliance effectiveness. The QE also applies project management principles to drive timely resolution of quality issues through cross-functional collaboration and leadership. This position is 100% onsite at the Dublin, OH manufacturing facility and includes performing scheduled Safety Inspections.

Responsibilities

• Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure.
• Performs NCMR Tracking & Trending (Data Analysis) to identify improvements for systemic issues.
• Uses problem-solving tools (e.g., 5WHYs, Ishikawa) to perform root cause investigations.
• Ensures maintenance or updating of risk documents such as PFMEAs, DFMEAs.
• Ensures compliance with Quality System Regulations (e.g., QSR 21CFR820 and ISO-13485).
• Supports qualification activities such as IQ, OQ, PQ; Test Method Validations (TMV), Gage R&R/MSA.
• Performs statistical analysis of manufacturing data using tools such as Minitab.
• Drives decision-making to resolve manufacturing quality or systems-related issues.
• Improves overall manufacturing processes to reduce internal and external escapes.
• Creates, reviews, or revises procedures for manufacturing processes and quality systems.
• Conducts Gemba walks of manufacturing areas to identify compliance risks and propose mitigations.
• Serves as QE Liaison for ICU Medical Customers, driving outgoing product quality improvements.
• Resolves internal and external customer quality issues and provides technical assistance for products.
• Interfaces with external suppliers to resolve supplier quality issues.
• Provides quality oversight for satellite locations as assigned.
• Creates data analysis charts, Pareto charts, and management meeting slides for leadership presentations.
• Develops action plans, project plans, or roadmaps to resolve issues.
• Collaborates cross-functionally across various levels and geographies of the organization.
• Leads or supports cross-functional initiatives as a Quality Engineering Subject Matter Expert.
• Participates in meeting departmental goals and objectives.
• Conducts Safety Inspections and takes prompt action to eliminate work hazards.
• Performs other related duties as assigned or required.

Requirements

• Experience with technical writing related to NCMRs, CAPAs, Engineering Investigations & Analysis.
• Experience reading Engineering Drawings, Manufacturing/Quality Technical Documentation.
• Experience with PFMEAs, DFMEAs, UFMEAs, Product Hold Orders, Issue Impact Assessments, Risk Assessments.
• Experience with Minitab or similar statistical analysis tools; Statistical Process Control (SPC).
• Experience with 21 CFR 820 and ISO-13485 or ISO9001 or equivalent standards.
• Knowledge of Lean Manufacturing (Toyota Production System), Standardized Work, First Time Quality, Kaizens.
• Strong analytical skills and ability to solve problems through analytical reasoning.
• Strong attention to detail and accuracy to identify and mitigate product quality and/or business risks.
• Experience working in a cross-functional, fast-paced manufacturing environment across all levels of the organization.
• Strong interpersonal skills and proven track record of teamwork, adaptability, innovation, and self-motivation.
• Strong Project Management Skills and ability to successfully balance multiple business priorities.
• Proficiency with PC skills, word processing, spreadsheets, project management, etc.

Qualifications

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited College or University is required, preferably in Engineering or STEM areas. Other areas may be considered based on experience.
• 2-4 years of experience.
• Previous regulated industry experience preferred.
• Experience in a clean room environment desirable.

Physical Requirements and Work Environment

The MQ Quality Engineer role receives general direction daily from Quality Engineering Management. The position requires duties in both manufacturing and office environments.

• Manufacturing Environment:
  • Work is performed in a clean room environment, requiring adherence to cGMP requirements.
  • Exposure to high noise areas, radiological hazards, lasers, and/or biological hazards may occur.
  • Must be able to occasionally move and lift objects of up to 40 lbs. unassisted.
• Office Environment:
  • Operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel less than 5% of the time.

About Us

ICU Medical consistently provides clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. Our focus allows us to bring dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization, along with the industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.