Job Title

Quality Engineer III, Metrology

FLSA

Exempt

Position Summary

Provide oversight and support of Quality Engineering Sustaining, Metrology operations including design and/or review, development, implementation, and maintenance of measurement programs, ensuring that all cGMP requirements are satisfied. Support validation and manufacturing operations by applying measurement science, mathematics, and physics to develop, document, and maintain measurement systems, procedures, and methods for dimensional, optical, physical, mechanical, environmental, and/or chemical inspection, measurement, and test equipment. (IM&TE) Evaluate new measurement methods and procedures. Use statistical methodologies to analyze measurement standards and processes.



The position requires good knowledge of the disciplines within a medical device Quality Management System (QMS) and knowledge and understanding of manufacturing and quality control processes.



Essential Duties & Responsibilities

Participate in design and review, execute, and implement various protocols in compliance with IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) requirements related to quality control / quality assurance manufacturing activities.

Provide hands-on technical support for setting and defining proper measurement techniques for various systems withing the company.

Develop measurement test methods, SOPs, and reports.

Provide technical training while qualifying and ensuring that all staff adhere to measurement protocols and cGMP requirements to comply with FDA standards.

Prepares system documentation, including user requirement documents, specification documents, test plans and user manuals for instrumentation.

Assists in interpreting and selecting measurement and calibration options that provide required accuracy.

Understanding of advanced measurement tools such as CT scanning

Perform Data Integrity/System Audit Trail Review functions for Instrumentation and conduct internal audits of Metrology documentation.

Ability to participate in vendor, client, internal and FDA audits, and generate the appropriate documentation required.

Perform all duties and all quality assurance / validation activities according to the applicable guidelines, i.e. FDA, GMP, ICH etc.

Ability to initiate problem-solving and technical decision-making commensurate with level of experience.

Written and oral skills at a level commensurate for interaction with staff, vendors, and clients as necessary.

Direct, plan, design, and coordinate development project activities.

Provide technical expertise to all project activities. Participate in short-and long-term strategic planning.

Performs other functions as necessary or as assigned.

Work on special projects as they arise.



Knowledge & Skills

Understanding of FDA and cGMP regulations and requirements.

Working knowledge and understanding of laboratory instrumentation and equipment.

Working knowledge with systems in use within the Medical Device industry.

Ability to train others.

Analytical and critical thinking skills.

Trouble shooting abilities.

Ability to communicate effectively with vendors, and all levels of staff.

Ability to work in a collaborative team environment.

Experience writing, reviewing and/or approving quality documents.

Good communication and leadership skills.



Minimum Qualifications, Education, & Experience

Bachelor's degree - in engineering or science field or equivalent and relevant formal academic/vocational qualification.

4 years+ experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, and experience.

Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.

Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook.



Work Environment

While performing the duties of this job, the employee is regularly required to talk or hear.

Must be able to lift at least 25lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.

This job requires computer work for hours at a time, along with standing and walking.

Typically requires travel 5-20% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.