Job Title —Quality Engineer

Company —Shoolin Inc

Location —San Diego, California.

Job Description:

  • o Provide support and expertise to a new product Introduction initiative by utilizing his Medical Device experience in Supplier Quality and Process Validation.

  • o Doing a lot of PPAP, Process Validation, PFMEA, Test Method Validation and Component Qualification of domestic and international suppliers. The bulk of these parts will have electro-mechanical pieces to them and/or PC board
  • o Involve with the cross functional team to complete the projects, report status, and document results in an efficient manner.
  • o Work independently with the general supervision on larger, moderately complex projects/assignment.
  • o Delivers and/or manages assigned projects and work with the other stakeholders to achieve desire results.
  • o Dealing with both large and small suppliers and must ensure they are staying compliant throughout.
  • o Keeps immediate supervisor and designated others accurately informed concerning work progress, including identifying present and future problems and solutions assignments.
  • o Utilize customer-facing skills and dealing with difficult suppliers at times who may not necessarily do a lot of work in an FDA regulated industry.
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  • o Utilizing good verbal and written communication skills to report project status to team members and management, productively interface with customers and suppliers, and document lesson learned.
  • o Prioritize multiple projects and meet delivery dates in a fast-Paced customer manufacturing environment.

Shoolin Inc requires its applicants to have at least a bachelor's degree or higher in an engineering discipline such as industrial engineering, Mechanical Engineering, or a closely related field.


Job Title —Manufacturing Engineer  

Company —Shoolin Inc

Location —San Diego, California.

Job Description: Manufacturing Engineer : Provide process engineering support for manufacturing transfer projects. Coordinate with applicable functions to draft and maintain documentation related to manufacturing transfer – including transfer plans and reports, control plans, validation strategies, master data in ERP system, PFMEAs, and First Articles. Initiates drawing changes with the product design engineer to improve manufacturing quality and reduce costs. Coordinates update of production order data as needed. Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs. Execute and support development of validation/qualifications studies. Complete activeis of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with CAPA System. Will work in unanticipated locations.

Requires Masters in Engineering Management, Industrial Management, Technology, or related.

Job Title —Validation Engineer  

Company —  Shoolin Inc

Location —San Diego, California.

Job Description:  Validation Engineer  : Provide technical expertise to define approaches and execution of system validation activities in accordance with applicable regulations, procedures, and industry guidance. Develop Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, quality standard policies and standard operating procedures, test protocols (Installation Qualification/Operational Qualification/Performance Qualification), and Summary Reports of critical manufacturing equipment, facilities, and utility systems. Execution of Test Protocols, including: identification and resolution of non-conformance/deviations. Develop change control activities for equipment and create various manufacturing processes and ensure proper justification of statistical analysis and hypothesis testing. Generate risk management deliverables such as System Impact Assessments, Criticality Assessments, Preliminary Hazard Analysis Assessments, and Risk Management Reports. Will work in unanticipated locations.

Requires Masters in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management or closely related field.