Quality Control Inspector

Reva Medical • San Diego, CA

12h

About The Position

Summary of Essential Duties and Responsibilities Perform mechanical, visual, and functional quality control inspection activities for raw materials, purchased components, in-process subassemblies and final assemblies in accordance with criteria defined within engineering drawings, manufacturing instructions and material and process specifications. Identify supplier and internal manufacturing/processing problems and issues, and work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence. Assist with the equipment calibration and preventive maintenance program, and coordinate such activities with both internal and external resources in ensuring compliance. Participate in special projects, performing first article inspections, test method validations, protocols, new test method development etc. Maintain and file inspection and test reports/records. Maintain the inspection areas in a clean and orderly fashion. Meet company and departmental goals in the continuous improvement of all products, services and processes. Comply with all relevant quality management system policies and procedures. Perform other duties as assigned. High school degree or equivalent. Ability to follow procedures, drawings, manufacturing instructions, test methods, and specifications. Ability to generate inspection status and trending analysis reports. Three to five years experience in miniature parts, mechanical and/or microscopic inspection within an ISO 9000, medical device, or similarly regulated environment. Experience with geometric dimensions and tolerances. Prior experience with testing or inspection of catheters or stents preferred. Ability to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel. Must have good documentation skills. Working experience using optical measurement systems, calipers – especially with tight tolerances, micrometer, tensile testers, and other general inspection equipment. Required Knowledge/Skills Good written and oral communication skills, and ability to read and understand English. High level of manual dexterity and attention to detail. Operate manual and computerized equipment following specified safety measures. Basic computer and math skills. Ability to work in a team environment. Frequent computer/report work, and administration of quality system programs and resources. Physical Demands/Working Environment 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 frequently required to sit or stand for prolonged periods of time. Specific vision abilities required by this job include close vision, and prolonged periods of microscope work. May be required to work overtime.

Requirements

• High school degree or equivalent.
• Ability to follow procedures, drawings, manufacturing instructions, test methods, and specifications.
• Ability to generate inspection status and trending analysis reports.
• Three to five years experience in miniature parts, mechanical and/or microscopic inspection within an ISO 9000, medical device, or similarly regulated environment.
• Experience with geometric dimensions and tolerances.
• Ability to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
• Must have good documentation skills.
• Working experience using optical measurement systems, calipers – especially with tight tolerances, micrometer, tensile testers, and other general inspection equipment.
• Good written and oral communication skills, and ability to read and understand English.
• High level of manual dexterity and attention to detail.
• Operate manual and computerized equipment following specified safety measures.
• Basic computer and math skills.
• Ability to work in a team environment.

Nice To Haves

• Prior experience with testing or inspection of catheters or stents preferred.

Responsibilities

• Perform mechanical, visual, and functional quality control inspection activities for raw materials, purchased components, in-process subassemblies and final assemblies in accordance with criteria defined within engineering drawings, manufacturing instructions and material and process specifications.
• Identify supplier and internal manufacturing/processing problems and issues, and work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.
• Assist with the equipment calibration and preventive maintenance program, and coordinate such activities with both internal and external resources in ensuring compliance.
• Participate in special projects, performing first article inspections, test method validations, protocols, new test method development etc.
• Maintain and file inspection and test reports/records.
• Maintain the inspection areas in a clean and orderly fashion.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Comply with all relevant quality management system policies and procedures.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED