What are the responsibilities and job description for the Quality Assurance Specialist position at Robling Medical?
Job Details
Summary:
The Quality Assurance Specialist is primarily responsible for performing receiving, in-process, and/or final inspections, functional testing, dimensional verification, and sampling incoming materials, parts, and mechanical assembly components used in disposable medical devices, electro-mechanical assemblies, and/or finished goods. The Quality Assurance Specialist will communicate and coordinate with suppliers regarding nonconforming materials, returns and corrective and preventive action requests. The Quality Assurance Specialist will provide assistance to manufacturing and quality in root cause analysis, corrective/preventive action, and rework of nonconforming materials. Other duties will include performing internal and roving audits, providing support to calibration program, and assisting with environmental testing and validation activities.
Primary Duties and Responsibilities
- Perform receiving, in-process, and/or finalinspections of purchased and customer owned parts for disposable medicaldevices and electro-mechanical assemblies
- Perform activities related to thedocumentation, control, disposition and root cause analysis of thenon-conforming material
- Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices
- Provide assistance, guidance, and oversight of manufacturing in the execution of rework activities
- Accurately document the results of theinspections and testing
- Maintain all controlled document files and testrecords in a timely and accurate manner
- Maintain a thorough understanding of individualcomponent specifications, blue prints, and sampling plans
- Write accurate and detailed non-conformingmaterial reports
- Communicate discrepancies or concerns with various suppliers and initiate and follow-up on Supplier Corrective Action Preventive Action requests.
- Conduct and document roving process, equipmentset-up, and system audits using written procedures as audit standards
- Monitor critical equipment and instrumentationto ensure proper operation and calibration
- Provide support to Quality Engineers in the testing and data collection during execution of validation activities
- Maintains safe and healthy work environment by following standards and procedures; complying with quality and legal regulations
- Provide support to the QA Supervisor in the maintenance of the calibration program and collection of bioburden samples /data
- Other duties as assigned.
Required Qualifications
- High School diploma or General Education Degree (GED) and applicable experience with at least 2 years of experience in the field.
- Excellent High School level math skills
- Experience with various measuring equipment (i.e., ruler, caliper, micrometer, visual measuring equipment)
- Ability to understand ANSI Z1.4 Sampling Plans
- Ability to read and understand mechanical drawings and blueprints
- Proficient computer skills (MS Word, Excel, PowerPoint, Outlook)
- Strong analytical skills and attention to detail
- Excellent interpersonal skills and verbal, written communication
- Demonstrated ability to effectively organize, prioritize, and accomplish multiple tasks, makes decisions, and solves problems independently.
Preferred Qualifications:
- Experience in an IOS 9001 or ISO 13485 manufacturing environment
- Experience in a manufacturing environment as a Quality Assurance or Control Inspector
- Medical device or pharmaceutical experience.
Environment & Working Conditions:
This position is generally performed indoors in a plant or office environment and requires specific physical requirements that must be met, including:
- Some lifting and moving of equipment (lifting up to 30 pounds)
- Standing for long periods of time
- Sitting for long periods of time
- Bending, kneeling, and ability to reach with hands & arms
- Visual– constant visual attention (i.e., color vision, depth perception, ability toadjust focus)
- Ability to use computers for long periods of time
- Employees work in clean rooms and must adhere to the dress code for that environment (includes gowns and hair covers).
Salary : $41,806 - $61,825