QA Engineer # JN -072019-47736

Employer
SSI
Location
Rancho Cordova, California
Salary
Not Specified
Posted
Jul 15, 2019
Closes
Sep 15, 2019
Job Type
Permanent
Hours
Full Time
Minimum Experience Required
5 years
Degree Required
4-Year Degree
Manages Others?
No
Description: 
  • In this role, you will promote and verify Q&R input and controls are applied to all operations activities including manufacturing, quality controls, warehousing, distribution and service activities and that all current and future processes, tools, software and systems are designed validated and released in compliance with applicable Regulations and Standards 
  •  

You are responsible for:  
  • Quality Assurance in the processes related to the manufacturing (internal and external), quality control, storage and distribution of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Q systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Q systems 
  • Providing support for regulatory actions and product containment activities (e.G., DPIAs, product holds, etc.) 
  • Providing support (Change Controls, CAPA/SCAR, NCR) of operations for NPI/Sustaining projects ensuring on time completion of project deliverables, correcting issues delaying completion and reporting on QMS status of projects 
  • Providing support of operations during internal and external audit/inspections 
  • Performing other duties as required 
  •  

Skills, Experience and Background:  
  • Bachelor’ s Degree in a Technical, Science, or Engineering discipline 
  • 5+ years experience in quality assurance/operations in a medical device industry 
  • Expert understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 13485: 2016 
  • Understanding of medical terminology and familiarity with standards of care and disease state 
  • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates 
  • Experience with Windchill/Trackwise/CATSWeb is strongly preferred  
  • ASQ Certification as CQE or DfSS/DMAIC Green Belt/Black Belt (or other recognized Accreditation bodies) is preferred  
  • Ability to travel 
  •  
  

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