Rebika Shrestha

Phone: 469-***-**** Email: adnj7q@r.postjobfree.com

Core Competencies:

• Experience on optimizing quality inspection routines, controls and assurance processes.

• Experience of performing internal supplier quality process and system audits per ISO 9001, ISO 13485 & 21CFR 820 standards.

• Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with CAPA process.

• Knowledge on manufacturing and inventory software; Minitab, SolidWorks, CAD/AutoCAD, DoE, SPC, Gage R&R, and Statistical Analysis, six sigma, 5s principles, Agile PLM, Oracle, eClinicalWorks, spreadsheet, and word processing software, such as Microsoft Office Suite.

• Proficient application of Geometric Dimensioning and Tolerancing (GD&T).

• Working knowledge on Surface Modification and Plasma Treatment, Injection and Blow Molding, Secondary Assembly Equipment, metal fabrication and plating.

• Strong accountability and project management for tasks with minimal supervision.

• Strong problem solving, communication and teamwork skills.

• Excellent communication skills both written and oral.

• Ability to multitask and manage workload efficiently and effectively. Experience:

Clinical Manager

The Vine Medical Center - Fort Worth, TX Dec 2018 to Present

• Work with team members of the clinical department in reviewing risk areas and providing recommendations to mitigate compliance risk.

• Assist in the development and implementation of internal policies, procedures, and work standards to help prevent and/or detect significant issues or ethical violations.

• Perform duties such as auditing, monitoring, tracking, reporting the department incident and inquiry logs using spreadsheets and electronic tracking system.

• Develop, analyze, and maintain monthly Performance Improvement for compliance, provide education or training presentations to staff and technicians on quality, competency evaluation.

• Assure programs meet accreditation and regulatory standards and comply with applicable laws, regulations, guidelines, standards regarding safety and infection control issues.

• Organize and follow HIPAA and privacy policies to the privacy and security of patient electronic medical filing

/records.

• Respond to sleep patient's procedural-related inquiries by providing appropriate education utilizing the sleep department-specific protocols.

• Perform routine equipment care, maintenance, and inventory evaluation providing technical helps in facilities to maintain quality performance.

• Holds weekly meetings and communicates with staff, Director of Sleep dept. Primary Care Doctor and Medical Director to provide quality healthcare services for each patient.

• Maintain current accreditation certificates, CPR or BLS certification, and continuing education credits

(CECs).

Supplier Quality Engineer

Hill-Rom, Batesville, IN Feb 2017- Mar 2018

• Worked Closely with Procurement and Engineering to establish the supply Chain structure for supplies selection, development, management with respect to performance, quality, delivery, and cost.

• Provided ongoing quality monitoring and interfaced with suppliers to improve process yields.

• Assisted suppliers to ensure that selection, development and validation of manufacturing processes, equipment, and tooling meets FDA, ISO 13485, and cGMP requirements.

• Participated in Material Review Board (ORB) to review and disposition nonconformities to coordinated supplier corrective actions.

Rebika Shrestha

Phone: 469-***-**** Email: adnj7q@r.postjobfree.com

• Reviewed and approved Supplier Part Approval Process Submissions including Dimensional layouts, statistical processes, data analysis, first article inspections, Material Certifications, Control Plans, Process failure Mode and Effects Analysis, Capabilities and Gage R & R Studies.

• Project lead to develop process for supplier change controls.

• Trained suppliers and internal staff to new process/ product requirements.

• Conducted supplier quality process and system audits and on-site risk assessments per ISO 9001 and ISO 13485.

• Supported management with supplier development strategies, initiatives, and quality system improvements.

• Resolves supplier component-related problems in incoming, receiving and manufacturing through MRP process and managed Supplier Corrective Actions (SCARs).

• Reviewed incoming material and / or in-process rejections and determine appropriate corrective actions.

• Actively participated in metrics development for supplier part cost, delivery, quality capacity and capability by using metrics to measure the required intervention or change at supplier or in commodity.

• Lead Quality Management Review meetings, trending analysis and reports on SCARS, CAPA and internal Audits.

• Used FMEA and control plans of new product development to support R& D department.

• Ensured compliance with applicable technical standards and assisted R& D in standard product safety testing per IEC 60601-1.

• Successfully completed metal, plastic, power cords and communication cable projects. Quality Engineer

Boston Scientific - Minneapolis, MN Mar 2016 to Jan 2017

• Worked for CAPAs, Non-Conformance Reports at Medical devices manufacturing under FDA Remediation Plan to meet cGMP and ISO quality standards.

• Reviewed, assessed non -conformance events, corrective and preventive actions (CAPA) including root cause analysis using Fishbone Diagram, 5 Whys, Is and/ or Is not, reporting, documentation, deviation, alignment of trending, and customer complaint analysis.

• Coordinated with the project team to perform process development and test validation deliverables such as Master Validation Plan (MVP). FMEAs, human Visual Inspection, Process Certifications of new AMS pump tester for Analytical Quality lab and Returned Components Analysis Lab.

• Provided direct technical support for the creation and approval of Engineering Change Order (CO), Change Request (CR) in Agile for the implementation of manufacturing process improvements.

• Supported site-wide FDA remediation to address company 486 observations, warning letters, including documentation reviews for compliance, and assisted in the completion of OFIs

(Opportunities for improvement) from Audit findings.

• Extensively involved in writing and reviewing A3 Executive summary project for the CPAPs and corrections with the owners and presenters,

• Participated in internal audits based on cGMP, IEC 62304, ISO 9001, ISO 13485. ISO 14971 regulations.

• Provided risk assessment on product nonconformance and field performance issues.

• Participated in supplier development problem-solving control tools such 8D, Process mapping, FMEAs, proofreading, SPC, Process Capabilities/ Cpk, GD&T, Gage R&R. Education

Master's in electrical engineering

University of Texas at Arlington - Arlington, TX

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