Boston Scientific Engineer II Quality Systems 

Costa Rica, Cartago 

370235759

Hybrid Roles:

Your Responsibilities Include:

• Support, plan, conduct, and oversee internal system audits according to applicable regulation to assess the effectiveness of the QMS and identify areas for improvement.
• Maintain audit records, findings, and corrective actions.
• Follow-up deadlines of planned corrective and preventive actions plans, and initiate escalation when necessary.
• Generate reports on quality performance and trends, providing insights to management for decision-making.
• Collaborate with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions (CAPAs).
• May act as CAPA Coordinator for the site. Provide guidance to owners about CAPA process and eCAPA system. Conduct CAPA Review Board and report required information to different forums.
• Support external audit readiness and participation on external audit scheduled for the site.
• Work closely with the business system process owners to drive continuous improvement.
• Use data analysis and key performance indicators (KPIs) to drive continuous improvement initiatives within the industrial sector.
• Improve, develop and deliver training programs related to the QMS specific, ensuring that employees understand and adhere to quality standards and procedures.
• Serve as a SME for Control of Documents, Internal Audits, Management of Non-Conformities, Problem Solving, Management Review and Training for IDL.
• Stay current with industry trends, regulations, and best practices to ensure the company's quality systems are up to date. Give input for continuous improvement strategies to support the organization’s manufacturing quality, cost reduction goals and standardization of processes.
• Understand and track quality plans, documents and systems by reviewing product and process specifications and quality systems requirements.
• Conduct onboarding training sessions for new employees.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining and improve of quality system.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, etc.
• Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.

What We’re Looking For:

• Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
• English Level: B2:(70-79%).
• Desired knowledge: ASQ certification (CQE, SSGB) desired, ISO standards, MDSAP, medical devices regulation.
• At least 2 years of experience in similar position.