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Quality Engineer II, Validation & Sustaining
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- Oracle
- Mid-level
Senior Engineer, Product
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- 7 years
- Office
Building Automation Technician
ICU Medical, Inc. —Salt Lake City, UT
- Weekends as needed
- 18 years or older
- Up to 50% travel
- System design
Quick Apply
Maintenance Technician, Automation - night shift
ICU Medical, Inc. —Salt Lake City, UT
- 12 hour shift
- 18 years or older
- Microsoft Excel
- Oracle
5d
Specialist, Import/Export
ICU Medical, Inc. —Lancaster, TX
- Full-time
- Microsoft Word
- 18 years or older
- Spanish
Engineer II, Molding
ICU Medical, Inc. —Dublin, OH
- Full-time
- 18 years or older
- Mid-level
- Office
Senior Engineer, Product Design
ICU Medical, Inc. —Southington, CT
- Full-time
- 18 years or older
- 7 years
- Analysis skills
Engineer III, Controls
ICU Medical, Inc. —Southington, CT
- Full-time
- 18 years or older
- Office
- Travel
Chemical Technician
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- Word processing
- Computer literacy
- Maintenance
Coordinator, Data Entry
ICU Medical, Inc. —Southington, CT
- Full-time
- 18 years or older
- Microsoft Excel
- Oracle
Engineer I, Tooling
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- Up to 50% travel
- Bachelor of Science
Senior Associate, Regulatory Affairs (Hybrid)
ICU Medical, Inc. —Lake Forest, IL
- $97,500 - $139,750 a year
- Full-time
- Hybrid work
- 18 years or older
- 7 years
- Mid-level
- Paid holidays
- Tuition reimbursement
Equipment Operator I
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- Microsoft Word
- 18 years or older
- Microsoft Excel
Manager, Engineering - Quality - Design Control
ICU Medical, Inc. —Lake Forest, IL
- $120,000 - $172,000 a year
- Full-time
- 18 years or older
- Office
- Analysis skills
- Paid holidays
- Tuition reimbursement
Quality Inspector I
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- Computer literacy
- Office
Senior Engineer, R&D
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- 7 years
- Office
Technical Engineer
Otsuka ICU Medical LLC —Austin, TX
- Full-time
- 18 years or older
- Mid-level
- Critical & Intensive Care
Manager, Warehouse
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- 5 years
- Office
Technician II, Repair
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- Oracle
- 5 years
- On-the-job training
Equipment Operator II
ICU Medical, Inc. —Salt Lake City, UT
- Full-time
- 18 years or older
- Microsoft Excel
- Microsoft Outlook

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Quality Engineer II, Validation & Sustaining

ICU Medical, Inc. -
Salt Lake City, UT

Apply Now

Job Details

Full-time

Qualifications

Customer communication
Bachelor's degree

Full Job Description

Position Summary

This role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products meet the highest standards of quality and regulatory compliance. The Quality Engineer II, Sustaining will work closely with cross-functional teams, including R&D, Advanced Manufacturing Engineering, Manufacturing, and Quality Assurance, to validate equipment, processes, and software used in production.

Essential Duties & Responsibilities

Demonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products.
Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems.
Conduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation.
Create and review Quality Control Plans and process FMEA’s,
Ensure validation documentation is accurate, complete, and in accordance with regulatory and quality system requirements.
Maintain validation master plans, protocols, and reports as part of the company’s quality system documentation.
Improve the Quality Management System through internal audits and supporting regulatory audits.
Lead and support the validation of new and existing manufacturing processes, ensuring compliance with FDA regulations, ISO 13485 standard, and company quality systems.
Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed
Must be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform analysis and resolve problems of moderate complexity.
Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
Updates Standard Operating Procedures and related QMS documentation, to complete improvement projects, as required.
Establish and maintain communication both internal and external (with the customers, molding, automation, assembly, product engineering, project management and regulatory personnel as needed)
Continually improve knowledge of relevant quality/regulatory topics and changes.

Knowledge, Skills & Qualifications

Knowledge of Agile PLM / Oracle (Desirable)
Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts.
Proficient in Minitab and Microsoft Office Suite
Strong communication skills and the ability to work collaboratively with cross-functional teams.
Able to multitask and work in a fast-paced environment.
High level of attention to detail and strong organizational skills.

Education and Experience

Must be at least 18 years of age
Bachelor’s degree in STEM from an accredited college or university
2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment required. Prior experience in quality is preferred.
Proficiency in using validation software and other relevant tools (e.g., Minitab, statistical analysis software).
Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).

Physical Requirements and Work Environment

This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Work is partly performed in a clean room environment
Must be able to occasionally move and lift objects of up to 25 lbs
Typically requires travel less than 5% of the time

Apply Now

Refine Your Search

icu medical jobs

Quality Engineer II, Validation & Sustaining

Senior Engineer, Product

Building Automation Technician

Maintenance Technician, Automation - night shift

Specialist, Import/Export

Engineer II, Molding

Senior Engineer, Product Design

Engineer III, Controls

Chemical Technician

Coordinator, Data Entry

Engineer I, Tooling

Senior Associate, Regulatory Affairs (Hybrid)

Equipment Operator I

Manager, Engineering - Quality - Design Control

Quality Inspector I

Senior Engineer, R&D

Technical Engineer

Manager, Warehouse

Technician II, Repair

Equipment Operator II

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