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Form of workJob Description
This is a NonExempt position
Summary
Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities
" Conduct product testing, including testing to support complaint investigations and stability verification
" Generate product testing results reports
" Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
" Conduct spot-check inspections/audits of production operations
" Participate in the internal audit program
" Write, review and approve Standard Operating Procedures (SOPs) as necessary
" May assist in supporting the Document Control program, record retention areas, and sample retention areas
" May support returned instrument processing
o Log returned instruments from the field.
o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Other duties as assigned by supervisor
Supervisory Responsibilities This job has no supervisory responsibilities.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
Education and/or Experience
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization.
Mathematical Skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Computer Skills
To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.
Certificates, Licenses, Registrations - None
Other Skills and Abilities
Ability to follow procedures and accurately document results
Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Attention to detail.
Ability to use bleach for cleaning purposes is required.
Other Qualifications - None
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
Summary
Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities
" Conduct product testing, including testing to support complaint investigations and stability verification
" Generate product testing results reports
" Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
" Conduct spot-check inspections/audits of production operations
" Participate in the internal audit program
" Write, review and approve Standard Operating Procedures (SOPs) as necessary
" May assist in supporting the Document Control program, record retention areas, and sample retention areas
" May support returned instrument processing
o Log returned instruments from the field.
o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Other duties as assigned by supervisor
Supervisory Responsibilities This job has no supervisory responsibilities.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
Education and/or Experience
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization.
Mathematical Skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Computer Skills
To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.
Certificates, Licenses, Registrations - None
Other Skills and Abilities
Ability to follow procedures and accurately document results
Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
Attention to detail.
Ability to use bleach for cleaning purposes is required.
Other Qualifications - None
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
