Robling Medical Incorporated

Careers

Robling Medical, Inc. is currently searching for the following positions.  With a great culture and strong leadership, we are  making a positive difference in patients’ lives everyday.

Open Positions

The QA Receiving Inspector’s primary responsibility is to perform receiving inspection, functional testing, dimensional verification, and sampling for incoming materials, parts, and mechanical assembly components used in disposable medical devices, electro-mechanical assemblies, and/or finished goods.  The receiving inspector will communicate and coordinate with suppliers regarding nonconforming materials, returns and corrective and preventive action requests.  The receiving inspector will provide assistance to manufacturing and quality in root cause analysis, corrective 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 

  • Performs receiving inspection on purchased and customer owned parts for disposable medical devices, as well as electro-mechanical assemblies
  • Accurately documents the results of the inspections and testing
  • Maintains all controlled document files and test records in a timely and accurate manner
  • Thorough understanding of individual component specifications, blue prints, and sampling plans
  • Writes accurate and detailed nonconforming material reports
  • Communicates discrepancies or concerns with various suppliers and initiate and follow-up on Supplier Corrective Action Preventive Action requests.
  • Conducts and document roving process, equipment set-up, and system audits using written procedures as audit standards
  • Monitors critical equipment and instrumentation to ensure proper operation and calibration
  • Provides 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
  • Other duties as assigned by the QA Manager

 Additional Duties and Responsibilities

  • Performs in-process and/or final inspection
  • Assists with root cause analysis, corrective action, and rework of nonconforming material
  • Conducts and document internal system audits using written procedures and regulatory standards
  • Provides assistance to manufacturing and quality assurance in the execution of rework activities
  • Performs review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices
  • Provides support to the QA Manager in the maintenance of the calibration program

Required Qualifications 

  • High school Diploma or equivalent
  • 2 + years Quality Assurance experience
  • Experience with various metrology equipment (i.e. ruler, caliper, micrometer, visual measuring equipment, etc.)
  • Strong comprehension and understanding of component specifications and mechanical drawings/ blueprints
  • Strong technical aptitude
  • Strong attention to detail
  • Ability to understand ANSI Z1.4 sampling plans
  • Strong arithmetic skill
  • Excellent written communication
  • Excellent verbal communication skills

Additional Qualifications (desired) 

  • Internal Audit experience with Food & Drug Administration (FDA) and/or International Organization of Standardization (ISO) 13485.
  • Optical comparator experience
  • 5 + years Quality Assurance experience (Receiving inspection preferred)
  • Medical device contract manufacturing experience
  • Understanding of Good manufacturing practices (GMP)
  • Understanding of sterilization validation and material biocompatibility requirements 

Environment & Working Conditions 

  • Lifting – 20 lbs
  • Standing or sitting for long periods of time
  • Bending
  • Use of rulers, calipers/micrometers, height gage, tensile and compression testing equipment, pressure decay tester, burst tester, optical comparator
  • Visual – constant visual attention
  • Clean room environment where gowns and hair covers are required

The QA Specialist’s primary responsibility is to perform product inspection and to review device history records along with providing support and training to manufacturing personnel.  The QA Specialist will be required to provide guidance and oversight to manufacturing in the management, root cause analysis, corrective action and rework of nonconforming materials.  Other duties will include performing internal audits and providing support to calibration program, assisting with environmental testing, assisting with receiving inspection.

Position: Quality Assurance Specialist
Department: Quality Assurance
Reports to (Title): Quality Assurance Manager
Manages: 0 Direct Reports
FLSA Status: Non Exempt

General Summary

The QA Specialist’s primary responsibility is to perform product inspection and to review device history records along with providing support and training to manufacturing personnel.  The QA Specialist will be required to provide guidance and oversight to manufacturing in the management, root cause analysis, corrective action and rework of nonconforming materials.  Other duties will include performing internal audits and providing support to calibration program, assisting with environmental testing, assisting with receiving inspection.

Primary Duties and Responsibilities

  • Perform receiving inspection, in-process and/or final inspection of disposable medical devices, as well as electro-mechanical assemblies
  • Perform activities related to the documentation, control, disposition and root cause analysis of the non-conforming material
  • Provide guidance and oversight of manufacturing in the execution of rework activities
  • Write nonconforming material reports, rework instructions
  • Train manufacturing employees
  • Provide support to the QA Manager in the maintenance of the calibration program
  • Provide support to the QA Manager in the collection and maintenance of bioburden samples and data
  • Provide support to Quality Engineers in the testing and data collection during execution of validation activities
  • Perform inspections for proper machine set up
  • Conduct internal audits
  • Other Duties as assigned by the QA Manager

Required Qualifications

  • High school graduate
  • Strong attention to detail
  • Strong technical aptitude
  • Ability to read and understand mechanical drawings/ blueprints
  • Ability to understand ANSI Z1.4 sampling plans
  • Strong math skills                                                                            
  • Experience with various measuring equipment (i.e. ruler, caliper, micrometer, visual measuring equipment
  • Proficiency in development and maintenance of Microsoft Word documents and Excel spreadsheets
  • Excellent written communication
  • Excellent verbal communication skills
  • Strong leadership skills

Environment & Working Conditions

  • Lifting –  20 lbs
  • Standing for long periods of time
  • Bending
  • Sitting for long periods of time
  • Use of rulers, calipers/micrometers, height gage, tensile and compression testing equipment, pressure decay tester, burst tester,
  • Visual –  constant visual attention
  • Primary work environment in clean rooms where gowns and hair covers are required.

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