Additional Locations: Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role
:Bring support to Quality department in the Complaints, Incoming, Quality Release and Quality Assurance Areas.
Youre Responsibilities Include
:May execute the following resposibilities:
:Inspector: QA
:Perform in process inspections to ensure established controls are being followed.
:Perform product inspection and testing to ensure the product meets the specifications established.
:Inspect labels, including the final packaging labels, for legibility and accurate information.
:Document inspection results accurately.
:Collect samples for validation tests, Bio burden, or if required by any investigation.
:Verify good documentation practices enforcement in documents used for product assembly. (DHR, forms, records, etc.).
:Verify good documentation practices enforcement in documents used for product assembly. (DHR, forms, records, etc.).
:Execute product approval and release activities (as per applicable procedures).
:Detect in process deviations, non:conforming material or any other situation that does not meet quality control specifications.
:Conduct process audits, as required, such as improvements actions or for investigations.
:Comply with assigned responsibilities as per applicable non:conforming material and rework procedures, which may include: a) Segregate and identify non:conforming material, both physically and electronically (non:conforming material control. b) Execute re:evaluation activities on reworked product.
:Inspector: Incoming
:Perform inspection activities on raw material, sub:assemblies, chemicals and other materials that require inspection.
:Conduct tests, measurements and visual inspection on product received at Boston Scientific Costa Rica. Assure inspected product meets requirements defined on drawings, diagrams and other documentation. Label product appropriately in order to ensure its traceability. Document inspection results on the appropriate forms. Create non:conforming material reports and properly dispose of it.
:Inspector: Quality Release
:Review DHRs in order to verify their compliance according to local and corporate procedures.
:Sustain and provide follow up on product release related tasks.
:Maintain and comply with good documentation practices and Boston Scientific Costa Ricas quality system
:Verify finished goods identification and inspection status at shipping area.
:Ensure packaging and palletizing status and proper location of finished product
:Control of finished product at NCEPs appropriate area.
:Support as necessary in prevention and correction of non conformances occurred at product release stage.
:Authorized to release finished devices as per activities required by Corporate and Local procedures for the Costa Rica sites.
:Inspector: Complaints
:Conduct analysis of returned product to determine the cause of failure.
:Perform lot history review of device history records.
:Assure that all laboratories equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
:Use measuring instruments; micrometer, caliper, pin gages, optical comparator, digital imaging and measurement system.
:Handle of biohazards devices trough all complaints (CIS) process decontamination and device analysis as applicable.
:Read and interpret technical drawings, procedures, BOM, and proto
