Engineer II, Quality

The Manufacturing Quality Engineer (QE) is responsible for providing oversight and guidance to manufacturing operations by ensuring compliance to industry standards and quality system regulations.

The QE will coach manufacturing and cross functional personnel on proper cGMP requirements to ensure a high-quality product is manufactured.

The QE will use Quality Engineering Principles and Continuous Improvement Tools to drive systemic improvements in Manufacturing Operations and Quality Systems and ensures compliance effectiveness.

The QE also uses project management principles to drive and ensure timely delivery of results and resolution of quality issues through cross functional collaboration, communication, and leadership across various levels of the organization.

The QE will be responsible for performing Safety Inspections on a scheduled frequency.

This role is 100% onsite at our Dublin, OH manufacturing facility.

• 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 (Ex: 5WHYs, Ishikawa etc.) to perform root cause investigations
• Ensures maintenance or updating of risk documents such as PFMEAs, DFMEAs etc.
• Ensures compliance with Quality System Regulations (Ex: QSR 21CFR820 and ISO-13485)
• Support qualification activities such as IQ, OQ, PQ; Test Method Validations (TMV), Gage R&R/MSA
• Perform statistical analysis of various types of manufacturing data using tools such as Minitab
• Drives decision making to resolve various 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 the manufacturing areas to identify compliance risks and propose mitigations
• QE Liaison for ICU Medical Customers (ICU supplied product to internal and external customers)
• Drives outgoing product quality improvements using quality engineering principles.
• Resolves internal and external customer quality issues and provide technical assistance for products
• May interface with external suppliers to resolve supplier quality issues
• Provides similar quality oversight functions for satellite locations as assigned or required.
• Creates data analysis charts, pareto charts etc., management meeting slides etc. and presents to leadership

• Creates action plans, project plans or road map to resolve issues
• Collaborates cross functionally and across various levels and geographies of the organization
• Drives timely resolution of the issues and completes projects in a timely fashion
• 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.

• Experience with Technical Writing related to NCMRs, CAPAs, Engineering Investigations & Analysis etc.
• 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 the ability to solve problems through analytical reasoning.
• Strong attention to details 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 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.
• PC skills, word processing, spreadsheets, project management, etc.

• 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

• The MQ Quality Engineer role receives general direction daily from Quality Engineering Management. The position requires both performance of duties in a manufacturing and office environment.
• While working in the manufacturing environment:
• Work is performed in a clean room environment. This requires the ability to adhere to the cGMP requirements of the area.
• There are high noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered.
• Must be able to occasionally move and lift objects of up to 40 lbs. unassisted
• While working in the office:
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time