Senior Quality Assurance Inspector 2nd Shift
ICU Medical, Southington, CT, United States
Sr Quality Assurance Inspector
The Sr Quality Assurance Inspector performs audit review on each batch record to ensure completeness and compliance before final release of products. This audit to assure the product has been manufactured in accordance with established quality standards. Sr. Quality Assurance Inspector is responsible to retain all batch records per retention procedure.
This role is 2nd shift (2:45 pm to 11:15 pm, Monday thru Friday) and is 100% onsite at our Southington, CT location.
Essential Duties & Responsibilities
Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version)
Execute final product release via iFactory / Oracle system
Access to Oracle Installed Base to update serial device information
Provides Manufacturing / MQA support to detect quality risks
Verify that the records documented are within the corresponding procedures
Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment
Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
File and retain batch records in controlled area per retention procedure
Ability to troubleshoot and work in a team environment
Other activities related to the position
Knowledge, Skills & Qualifications
Excellent Mathematical knowledge
Good knowledge in records filing
Good computer knowledge
Ability to comprehend both verbal and written instructions
Education and Experience
Must be at least 18 years of age
High School Diploma or GED required
Experience with medical devices/pharmaceutical GMPs preferred
Minimum of 2 years in a FDA regulated manufacturing environment
Physical Requirements and Work Environment
While performing the duties of this job, the employee is regularly required to talk, hear and communicate on phone and through email.
While performing the duties of this job, the employee is regularly required to sit which is mainly on the computer with some standing during shift
Must be able to repetitively move and lift objects of up to 20 lbs
Typically requires travel less than 5% of the time
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 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.
Job Identification 1161
Job Category Inspection
Job Schedule Full time
Locations Southington Plant (On-site)
The Sr Quality Assurance Inspector performs audit review on each batch record to ensure completeness and compliance before final release of products. This audit to assure the product has been manufactured in accordance with established quality standards. Sr. Quality Assurance Inspector is responsible to retain all batch records per retention procedure.
This role is 2nd shift (2:45 pm to 11:15 pm, Monday thru Friday) and is 100% onsite at our Southington, CT location.
Essential Duties & Responsibilities
Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version)
Execute final product release via iFactory / Oracle system
Access to Oracle Installed Base to update serial device information
Provides Manufacturing / MQA support to detect quality risks
Verify that the records documented are within the corresponding procedures
Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment
Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
File and retain batch records in controlled area per retention procedure
Ability to troubleshoot and work in a team environment
Other activities related to the position
Knowledge, Skills & Qualifications
Excellent Mathematical knowledge
Good knowledge in records filing
Good computer knowledge
Ability to comprehend both verbal and written instructions
Education and Experience
Must be at least 18 years of age
High School Diploma or GED required
Experience with medical devices/pharmaceutical GMPs preferred
Minimum of 2 years in a FDA regulated manufacturing environment
Physical Requirements and Work Environment
While performing the duties of this job, the employee is regularly required to talk, hear and communicate on phone and through email.
While performing the duties of this job, the employee is regularly required to sit which is mainly on the computer with some standing during shift
Must be able to repetitively move and lift objects of up to 20 lbs
Typically requires travel less than 5% of the time
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 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.
Job Identification 1161
Job Category Inspection
Job Schedule Full time
Locations Southington Plant (On-site)