Easter Seals Jobs

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 sca nning
• 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 combin ation 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.

About Us

ICU Medical has consistently provided you with 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.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

"Know Your Rights" Poster Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants