Quality Systems Specialist
ECA Medical Instruments ECA Medical Instruments Newbury Park, CA Newbury Park, CA Full-time Full-time $23.
64 - $30.
00 an hour $23.
64 - $30.
00 an hour Job
Summary:
Responsible for effective and accurate coordination of all quality documents within the Quality Management System.
Working in a medical device, regulated environment, coordinate the document control system to ensure compliance of internal and external requirements.
Duties and Responsibilities Responsible for coordination of the change control processes Support execution of Corrective Actions (CAPA system).
Supports external audits.
Follow policies and procedures pertaining to best documentation practices.
Ensures documents are readily available in electronic format and accessible to all employees.
Develops procedures and forms required for control of documentation and documentation activities Responsible for electronic and hard-copy archival system for controlled documents Manage document changes and approvals Manages part revision controls in the ERP Systems Creates and maintains documentation such as quality procedures and work instructions, including assignment of document numbers Develop and provide metrics on the status of change control process Manage and control external documents Supports Training program, entering training, monitoring completion and preparing metrics.
Assist with the performance and documentation of Internal Audits Provide training of personnel on the procedure management process as required Assign numbers for deviations, rework instructions and engineering documentation Oversees work assignments of the Document Control Assistant Manage and maintain training matrix and job by function report; notifies managers and supervisors when training is due Prerequisities Bachelor's degree preferred but not required Experience with technical documentation and ERP in a medical device environment or manufacturing environment Experience with document control and change order process Intermediate/advanced skills with MS Word and MS-Excel and ERP systems software Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and exemplary customer service.
Work Environment While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving mechanical parts and vibration.
The employee is occasionally exposed to a variety of varying weather conditions.
The noise level will also vary, depending on location.
The employee may spend several hours entering information into a computer and sitting for long periods of time.
Physical Demands Sitting, standing, walking, bending, lifting up to 20lbs; pull/push up to 40 lbs, grasp small device/products and identify very small variations in the product.
Sight is required for observing work and production.
May spend several hours using a computer to create reports, analyze data and respond to inquiries and issues.
While performing the duties of this job, the employee is regularly required to talk and hear.
May be exposed to active machinery and moving equipment.
Job Type:
Full-time Pay:
$23.
64 - $30.
00 per hour Expected hours:
40 per week
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Vision insurance Experience level:
1 year Schedule:
8 hour shift Work setting:
In-person Office Ability to Relocate:
Newbury Park, CA 91320:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
64 - $30.
00 an hour $23.
64 - $30.
00 an hour Job
Summary:
Responsible for effective and accurate coordination of all quality documents within the Quality Management System.
Working in a medical device, regulated environment, coordinate the document control system to ensure compliance of internal and external requirements.
Duties and Responsibilities Responsible for coordination of the change control processes Support execution of Corrective Actions (CAPA system).
Supports external audits.
Follow policies and procedures pertaining to best documentation practices.
Ensures documents are readily available in electronic format and accessible to all employees.
Develops procedures and forms required for control of documentation and documentation activities Responsible for electronic and hard-copy archival system for controlled documents Manage document changes and approvals Manages part revision controls in the ERP Systems Creates and maintains documentation such as quality procedures and work instructions, including assignment of document numbers Develop and provide metrics on the status of change control process Manage and control external documents Supports Training program, entering training, monitoring completion and preparing metrics.
Assist with the performance and documentation of Internal Audits Provide training of personnel on the procedure management process as required Assign numbers for deviations, rework instructions and engineering documentation Oversees work assignments of the Document Control Assistant Manage and maintain training matrix and job by function report; notifies managers and supervisors when training is due Prerequisities Bachelor's degree preferred but not required Experience with technical documentation and ERP in a medical device environment or manufacturing environment Experience with document control and change order process Intermediate/advanced skills with MS Word and MS-Excel and ERP systems software Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and exemplary customer service.
Work Environment While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving mechanical parts and vibration.
The employee is occasionally exposed to a variety of varying weather conditions.
The noise level will also vary, depending on location.
The employee may spend several hours entering information into a computer and sitting for long periods of time.
Physical Demands Sitting, standing, walking, bending, lifting up to 20lbs; pull/push up to 40 lbs, grasp small device/products and identify very small variations in the product.
Sight is required for observing work and production.
May spend several hours using a computer to create reports, analyze data and respond to inquiries and issues.
While performing the duties of this job, the employee is regularly required to talk and hear.
May be exposed to active machinery and moving equipment.
Job Type:
Full-time Pay:
$23.
64 - $30.
00 per hour Expected hours:
40 per week
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Vision insurance Experience level:
1 year Schedule:
8 hour shift Work setting:
In-person Office Ability to Relocate:
Newbury Park, CA 91320:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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