ICU Medical · 19 hours ago
Engineer II, Quality
Southington, CT
Full-time
Onsite
Mid LevelICU Medical, Inc. is a company focused on quality in manufacturing processes. The Manufacturing Quality Engineer is responsible for ensuring compliance with industry standards and quality system regulations, driving improvements in manufacturing operations, and resolving quality issues through cross-functional collaboration.
Health CareMedical Device
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 (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
Qualification
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
Previous regulated industry experience preferred
Experience in a clean room environment desirable
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase