Duties: Provides independent evaluation of materials, components, and products, and work process within the quality system Quality and production support resource to ensure compliance with policies and procedures within an atmosphere of error prevention and continual improvement.
Main responsibilities:
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Review material, equipment, and systems quality through examination, inspection, measurement, or testing of raw materials, components, sub assembly, final assembly, packaging, labeling and documentation.
• Contributes to validation testing as defined on validation protocols with engineering guidance. Ensures that all evidence documentation complies with governing procedures.
• Executes product acceptance testing, sampling, inspection, classification or disposal based on engineering dispositions.
• Perform measurement for small parts with CNC or Vision System such as Smartscope and Pull Testing
• Ensures that all evidence documentation complies with governing procedures.
• Audits and verifies processes such as line verification or environmental conformity to prevent quality system and manufacturing impact.
• Reviews and verifies compliance of documentation such as batch records, reports of nonconforming materials, inspection records.
• May be required to scan, archive, and coordinate record retrieval.
• Notifies supervision of issues or errors, providing immediate response.
• Executes Testing of samples as part of its daily activities with minor guidance from Quality Supervisor or Quality Engineer.
• Identifies and segregates nonconforming material from the production line according to governing documents. Coordinates with the Quality Engineer to prepare and handle the material in and out of the designated quarantine area.
• Inputs data to required systems. CATSWeb use is limited to run queries and/or input lots, test data.
• Assists to set up, train and certified new or transferred Quality Technicians.
• Provides ideas for improvement in areas such as quality, productivity, and safety.
• Contributes to generate work schedules when required by Quality Supervisor.
Skills:
• Detail oriented
• GMP Background
• Vision System experience. Abbott uses Smartscope, but other brand experience is okay.
• Can record data.
• Worked with Quality system regulations.
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 Log returned instruments from the field. Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required. Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
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.
Target Pay Rate Range: $20-25/hr. Salary will be commensurate with experience and may fall outside of this range
