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Technician, QA - 2nd ShiftICU Medical • Southington, Connecticut, United States
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Technician, QA - 2nd Shift

ICU Medical
  • US
    Southington, Connecticut, United States
  • US
    Southington, Connecticut, United States
Jetzt Bewerben

Über

Supports the Company’s mission to produce safe and effective medical devices. Supports the Quality Management System (QMS) through driving dispositions for non-conforming product and improving test methodology. Assist the production / quality teams in collecting and analyzing data for measurement systems analysis, capability studies, design of experiments, etc.
This position is 2nd shift (2;45pm-11:15pm) and is 100% onsite at our Southington, CT manufacturing facility.
Participate in the establishment and/ or revision of quality specifications and standards for raw materials and for 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 their product lines.
Participate in MRB review meetings
Provide weekly/monthly feedback to management about the progress of actives
Completes daily assignments in a safe and effective manner
Ensures assignments are completed timely and accurately in accordance with applicable departmental procedures.
Complies 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 assignment by supervisor
Knowledge & Skills
Strong attention to detail and accuracy
Proven ability to work with all levels of the organization
Ability to work in a team environment
Strong communication skills (written and oral)
Ability to plan and prioritize activities
Ability to exercise independent judgment
Knowledge of GMP, and other appropriate regulations and standards applicable to the workplace
Ability to handle confidential information
Basic computer skills
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.
Vision requirements include close vision, distance vision, color vision, peripheral vision and depth perception.
Minimum Qualifications, Education & Experience
High School Diploma or equivalent, plus three years of Quality Manufacturing experience. Technical aptitude is required. A two-year degree in a technical field is preferred.
Familiarity with US FDA 21 CFR Part 820, ISO 9000/13485/14001.
Experience in a medical device field is desirable
ASQ certification is desirable.
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 being an 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, 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.
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  • Southington, Connecticut, United States

Sprachkenntnisse

  • English
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