Job Title — Cleaning Validation Engineer

Company —Vastek Inc.

Location —San Diego, California.

Job Description:

  • • Work with cleaning validation and executes protocols.
  • • Assist suppliers in developing inspection methods.
  • • Perform Gage R&R and correlation studies.
  • • Work with QA Technicians to resolve measurement and testing issues.
  • • Work with QA departments to resolve blueprint/specification issues.
  • • Work with other departments to resolve issues related to material and process quality, including FMEA, DOE, SPC.
  • • Develop Control Plans, Inspection Instructions, and other documents as needed to effectively manage product/process.
  • • Investigate and resolve protocol exceptions or discrepancies
  • • Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.
  • • Perform risk assessments and impact assessments.
  • Requires Masters in Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title — CSV Lead

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek, Inc. has openings in San Diego, CA) CSV Lead: Provide guidance on computer and automation systems validation. Compile and analyze validation data and recommend changes and/or improvements to system/software. Conduct timely validation of security patches in the system. Coordinate and execute training of required personnel on the computer and automation systems validation procedures and methodology. Review and approve change controls, risk assessment reports, and system and user testing protocols. Utilize QSR, CAPA, qtest, JIRA, and Comala Workflow. Will work in unanticipated locations.

    Requires Masters in Computer Science, Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Product Development Engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek, Inc. has multiple openings in San Diego, CA) Product Development Engineer: Plan, develop, modify, implement, and support products through the application of design control, change control, and engineering practices. Develop new concepts from initial design to market release. Write proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts. Execute protocols and reports as needed to support validation activities, including Design Verification. Conduct feasibility studies of designs to determine ability to function as intended. Maintain detailed documentation throughout all phases of product development. Conduct risk analysis for products under development. Participate in client meetings and communicate with the team to ensure a two-way exchange of information. Execute product development deliverables from concept through commercialization. Will work in unanticipated locations.

    Requires Masters in Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Quality Assurance Analyst

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek Inc. has openings in San Diego, CA) Quality Assurance Analyst: Develop validation and testing strategies for systems/applications that are within the scope of validation affiliated with FDA regulations. Review the validation framework and validation plans before the testing of the system. Review and validate quality deliverable and system documentation against federal requirements. Approve quality deliverable and validation report. Ensure that validated systems are in accordance with regulatory requirements and quality objectives. Identify and review potential hazards and risks in systems/applications that are subjected to validation. Ensure that risk analysis, risk mitigation strategies, and modes of control are performed and documented. Ensure that defects generated from the testing process are reviewed and resolved prior to system production. Verify that all components of the system are tested together and ensure the system performs functionally and operationally. Confirm validation evidence is complete and documented. Verify that the system operates according to requirements and design specifications. Will work in unanticipated locations.

    Requires Bachelor’s in Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Quality Engineer (Job Code 001)

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description: (VAStek, Inc. has openings in San Diego, CA) Quality Engineer (Job Code 001): Support the validation team in writing qualification protocols and reports. Perform root cause investigations and CAPA process using quality tools. Develop and execute design of experiments and pre-validation activities. Assist in the development, implementation, and strict adherence to quality management systems. Develop and maintain quality control plans. Assist in the development and maintenance of PFMEAs. Provide CAPA responses to customer issues and audit findings. Perform Gage R&R and MSA and write test/inspection methods and procedures. Review design changes working closely with R&D in the transfer of safe and effective medical devices. Perform quality related activities and provide technical quality engineering support for design qualifications, design transfer, activities for regulatory submissions, product/process development, implementation of design control documents, and approval of product/process change. Will work in unanticipated locations.

    Requires Master’s in Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Regulatory Affairs Specialist

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description: (VAStek Inc. has openings in San Diego, CA) Regulatory Affairs Specialist: Document product drawings, material test reports, and design dossiers for NMPA submissions and 510(k) clearance letters from the FDA. Review regulations of the NMPA and FDA. Update dossiers with the current regulations for remediation projects and prepare TRD dossiers for new submissions. Analyze and remediate gaps in TRD to ensure compliance with ASTM and ISO standards. Deliver regulatory support for TRD remediation projects to rectify current submissions and to develop accurate license extension/renewal dossiers for medical devices. Integrate findings from TRD remediation projects with new product submissions to eliminate risks and ensure timely approvals. Assess regulatory risks and review regulatory justifications to address deficiency letters issued by the NMPA. Perform detailed regulatory impact assessments and present comprehensive global regulatory strategies. Will work in unanticipated locations.

    Requires Master’s in Engineering or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.

    Job Title — Validation Engineer (Job Code 002)

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek Inc. has multiple openings in San Diego, CA) Validation Engineer (Job Code 002): Support and review equipment, process, and facility qualification and validation activities. Create and update master design verification and design validation documents for existing products. Execute test protocols and test method protocols. Analyze test scripts. Perform qualification and design verification testing. Identify defects in product design, verification, validation, manufacturing, and testing activities. Perform root cause analysis. Write and execute risk assessment and procedures and perform risk management activities. Conduct quality assurance tests and improve the quality of products. Will work in unanticipated locations.

    Requires Master’s in Computer Science, Engineering, or related.

    Send resume to and refer to job title to swapna@vastekgroup.com.

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