Technician, QA
ICU Medical, Inc.

Job Info

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Job Description

Essential Duties & Responsibilities

• Participate in the establishment and/ or revision of quality specifications and standards for raw materials, in-process and finished products.
• Support the development and revision of inspection and testing procedures for raw materials, in-process and finished products
• Support investigations on product defects to identify root cause and potential corrective action.
• Provide technical assistance and support to the manufacturing teams for designated product lines. Provide guidance in the completion of required documentation and records.
• Participate in MRB review meetings
• Provide weekly/monthly feedback to management about the progress of activities
• Ensure assignments are completed safely, effectively, timely and accurately in accordance with applicable departmental procedures.
• Comply with the requirements, responsibilities, and authority as outlined in the System Manual and SOP's. Must keep aware of changes in GMP and other regulatory requirements that affect the company quality plan.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
• Other duties as assigned or directed

Knowledge & Skills

• Strong attention to detail and accuracy
• Strong communication skills, with a proven ability to work with all levels of the organization
• Ability to work in a team environment
• Ability to plan and prioritize activities, and exercise independent judgment
• Knowledge of GMP, and other appropriate regulations and standards applicable to the workplace
• Ability to handle confidential information
• Demonstrated capability in the use of a computer
• Vision requirements include close vision, distance vision, color vision, peripheral vision and depth perception.

Minimum Qualifications, Education & Experience

• High School Diploma or equivalent. Technical aptitude is required. A two-year degree in a technical field is preferred.
• Three years of Quality Manufacturing experience.
• Familiarity with US FDA 21 CFR Part 820, ISO 9000/13485/14001.
• Experience in a medical device field is desirable

Work Environment

• While performing this job, an employee is required to stand, walk and use hands to handle materials. The employee is frequently required to reach with hands and arms and to talk and hear. The employee is occasionally required to stoop, kneel, or crouch.
• This position is occasionally required to lift up to 50lbs and move more than 100lbs.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% 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

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