Job Description

Location: [[city]], [[stateProvince]], [[country]]
Additional Locations: Malaysia-Penang
Hiring Manager: [[hiringManagerName]]
Recruiter: Jason Tan

Purpose Statement

Routine final functional testing, product release criteria testing/inspection and recording of test results. Review and update of QA Documentation.Controlling closed Exception Reports/Non Conformances Reports, Line Audits & Non Conforming Report Board Reports that are generated. Compiling Non Conformance Board Reports monthly & various documents for Management on an ad hoc basis.

Key Responsibilities

• Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components, sub assemblies, final assemblies and documentation.
• Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature).
• Handle discrepant materials per the documented disposition and document activities in the appropriate systems or paperwork.
• Communicates the status of audit metrics and other assignments, responsibilities, and duties verbally and through the completion and publishing of periodic reports.
• Performs simple statistical analysis through the collection and input of data into software applications or manual calculations.
• Review and update of QA Documentation.
• Validation Protocol preparation ,execution and report writing including Equipment Qualification.
• Peform the finish Goods inspection and Active releases .
• Resposible for PSRR and E-releases process.
• Trains new, entry level, and less experienced Quality Auditors through on-the-job training, group training, and one-on-one guidance.
• Compliance to all QA Laboratory and all relevant plant wide procedures and practices.
• Compliance to all ISO9001 and current GMP procedures and practices.
• Provision of excellent service to all internal customers for the IQA laboratory area.
• Provide technical guidance if required on the evaluation of the material.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Provides an independent, unbiased evaluation of material for the Non Standard Work Order (NSWR), whenever required.
• Issues, stores, count and maintains inventory into the different storage areas. Handles, disposes, transfer and document appropriately hazardous waste.
• Perform and assist with additional duties as may be directed by the Supervisor /Manager
• Reads, comprehends and follows basic job instructions and/or protocols including verbal, written, diagramed, colored, etc. and other work related documents; written in English.

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you\xe2\x80\x99re looking to truly make a difference to people both around the world and around the corner, there\xe2\x80\x99s no better place to make it happen.

Requisition ID: 569121

Boston Scientific