Clerk Cis Investigator Coyol jobs at Boston Scientific in Costa Rica, El Amparo

Costa Rica-Coyol

About the role:

Responsible for the efficient management of production resources: equipment, personnel and materials.

Your Responsibilities Include:

• Oversee operations efficiency and standardization.
• Directly responsible for complying with the production plan and the quality of the product, as well as for line personnel.
• Analyze and evaluate process improvements in order to reduce defects and scrap and/or improving yields.
• Follow procedures established for each operation, and keep work areas organized and clean at all times.
• Participate and/or lead problem solving processes, whether due to increasing trends on complaints, defects, scrap, or low productivity, among others.
• Provide feedback to PB IV.
• Support employee-safety oriented initiatives: rotation programs of line personnel, use of safety equipment in the production area, and EH&S awareness programs.
• Support EHS management system: responsible of understand, know and apply EHS policy. Responsible to acknowledge and inform the environmental aspects and health and safety risks relevant to mitigate, reduce and eliminate impact during operations.
• Monitor and update the department´s metrics: Yield, Efficiency, Plan Compliance, RCTIME and Quality.

What we're looking for:

• Bachelor or Licenciature degree in Business Administration, Industrial Engineering or Related Field.
• English Level desired: 70-79%
• Experience: At least 2 years
• Technical Competencies: Problem Solving Methodologies.

About the Role:

To provide quality insights and/or support to product complaint investigations. To analyze, measure, improve, and document investigation results of BSC manufacture products.

Your Responsibilities Include:

• Perform complaint product investigations.
• Perform documentation review, including Device History Record, Risk documentation, and Labeling review, among others.
• Perform product dimensional, functional, and/or visual testing to confirm failure modes.
• Perform basic statistical analysis and communicate results to teams.
• Contribute and/or support CAPA as well as NCEP activities.
• Identify areas of improvement and participate in continuous improvement projects.
• Support internal audit activities.
• Use documentation systems to research information and generate Change Requests, as necessary.
• Assist in developing and qualifying test methods, data sheets, test fixtures, and testing equipment.
• Supports product integrations and/or transfers from other complaint sites.
• Train peers on processes and/or products.
• Update databases and spreadsheets used to track, monitor, and report product results.
• Supports additional tasks required in the complaint’s laboratory.

What We’re Looking For:

• Technical Degree in Quality, Electric Engineering, Electromechanical, Biotechnology, Chemical, Customer Service or medical related.
• Intermediate English Level (B2) is a must.
• Preferred Medical Device Industry experience.

Costa Rica-Coyol

About this role:

Responsible for providing technical acumen and data analysis for the Endoscopy division of Boston Scientific for Post Market Reporting assessments (Periodic Safety Updates). The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role identifies, analyzes, helps to investigate, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. The role communicates and educates management, R&D, marketing, Design Assurance, plant QA, clinical, and other departments, as well as potentially external customers about complaints monitoring trending and product performance. The role will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.

Responsible for identifying and helping with implementing continuous improvements to improve product performance and the post market support processes. This role provides visibility across site, cross division and with divisional leadership.

Your responsibilities will include:

• Analyzing customer complaints, compliance events, clinical data and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
• Investigating potential and/or identified trends or data issues with cross-functional teams across the division.
• Manage potential actions by updating the Post Market report at appropriate intervals and levels by performing, when necessary, a Health Risk Analysis and/or Risk Management Analysis reviews.
• Documenting data reviews, trend analysis, escalations and actions as an output in formal regulatory submission report (PSUR) for Notified Body review and agreement.
• Communicating product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to continue to improve process and product performance.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• Provides input for process improvement and helps develop tactical approaches to implement team strategies.

Minimum Qualifications

• Bachelor’s degree with an Engineering or Science background
• English Level B2 (70-79%).
• Strong communication and presentation skills. Comfort speaking to groups of individuals.
• Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
• Demonstrated problem-solving & critical thinking.
• Capable working in a regulated environment with clinical teams including review of clinical data and analysis of clinical terminology
• Advanced knowledge of Microsoft Excel
• Proficient with Microsoft Office tools including Word, PowerPoint, Teams and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task and adaptability
• Attention to detail and accuracy in data analysis and documentation.

Preferred Qualifications

• ISO 13485 or MDR knowledge
• Knowledge of analytical techniques, problem solving, continuous improvement programs, data analytics and statistical analysis
• Demonstrated statistical analysis & data analysis capabilities
• Self-starter with the ability to identify improvement opportunities.
• Experience with and/or knowledge in Quality System Regulations, Medical Device Regulation, and Quality Standards.
• Demonstrated understanding of risk management
• Familiarity with Post Market Surveillance requirements and IT systems
• Experience in working across multiple product areas and cross functionally with DA, R&D and Manufacturing teams
• Professionalism to represent BSC to external entities

Costa Rica-Coyol

Hybrid Roles:

About the role

Responsible fortraining and mentoring technicians who work on investigation of return and not-return products

Your responsibilities include:

• Approving product analysis for return and non-return complaints related to Capital Equipment (Electonic Hardware/Software/Firmware) performed by technicians at other sites
• Approving product analysis for return complaints related to RF products performed by technicians at Coyol site
• Approving product analysis for non-return complaints related to all other NM products performed by technicians at Coyol site
• Coordinating and supervising failure investigation activities of lab technicians
• Maintaining the CIS lab and its equipment as needed
• Creating and presenting slides for SER/CRB
• Collaborating with Post Market (CCC/CMC) and other teams involved in complaint handling and return process
• Being responsible for all product monitoring MIDs and corresponding SEFs
• Creating, releasing new WI/SOPs in document control system
• Initiating and owns non-conformance investigtions
• English Language 80%

Required Qualifications:

Minimum Qualifications

• Bachelor’s degree in Electrical/Electronics Engineering with 2+ years of relevant experience
• Demonstrated problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Ability to collaborate with other teams
• Ability to successfully multi-task and be adaptive
• Please Submit Resume in English
• English Level Desire 80%

Preferred Qualifications

• 1-2 years experience in similar role
• Experience in Medical Device industry

• Familiarity with Post Market requirements and systems

Costa Rica-Coyol

Hybrid Roles:

About the role

Responsible for

You will be identifying, coordinating, and assigning project priorities based on business and department objectives.Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. Will help develop and maintain a robust CIS training program.

Your responsibilities include:

• Providing leadership to a team of Quality Technicians & Quality Engineer(s) to champion departmental or cross-functional initiatives. This includes providing direction, coaching, and mentoring to technical team personnel as well as providing guidance on daily work priorities to improve product performance.
• Creating a robust training plan/curriculum for all technicians/engineers
• Creating a pipeline of future hires thru advance planning for talent and onboarding of suitable interns
• Owning and maintaining all departmental SOPs/WIs
• Fostering excellent cross functional communications and collaboration with other functions (Decon. team, CMS, CCC, Sales Support, Patient Care, R&D, Mfg site, others).
• Conducting regular staff and 1-on-1 meetings with direct reports
• Conducting end continuous performance reviews and career development discussions with direct reports
• Implementing a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
• Assigning relevant trainings to new hire and provide them with technical guidance as needed
• Overseeing effective execution of complaint management WIP and adjusting workloads to maintain green metrics.
• Being responsible for all CIS related metrics
• Maintaining the CIS lab and its equipment as needed
• Actively working with all other CIS locations to ensure effective implementation of best practices.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations
• Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Reviewing and approving timecards for hourly employees
• Conducting annual performance reviews and recommending compensation adjustments annually based on performance demonstrated
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required Qualifications:

Minimum Qualifications

• Bachelor’s degree with an Engineering or Science background with 5+ years of relevant experience
• Demonstrated problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Good verbal and written communication skills
• Ability to multi-task and be adaptive
• English Language 80%
• Please submit Resume in English

Preferred Qualifications

• 5 years of Supervisory experience
• Experience in Medical Device industry

• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-motivated with the ability to identify improvement opportunities
• Efficiently present performance and issues to peer and senior management audiences
• Familiarity with Post Market requirements and systems

Costa Rica-Coyol

Hybrid Roles:

About the role

Performs quality activities to support testing and failure analysis of returned products. Understands all governing SOPs/WIs for CIS work and performs all work compliant to them. Documents all testing/analysis results and overall conclusion in GCMS. Works closely with other technicians and quality engineers in CIS. Identifies opportunities to improve the quality of the product investigated.

Your responsibilities include:

• Performing troubleshooting and analysis of all electrical/electronic/mechanical aspects of returned devices with user complaints
• Documenting all investigations/analysis results in GCMS
• Identifying areas of improvement both for product and process
• Training to all documents and procedures related to the role in a timely manner
• Assisting in maintaining CIS lab and its equipment
• Working closely with quality engineer to update investigation results based on feedback
• Performing product record reviews as needed
• Assisting in decontamination of returned samples as needed
• Performing SAP transactions for returned products as needed
• Assisting in archival of complaint samples post investigations per procedure

Required Qualifications:

Minimum Qualifications

• Associate degree or better in Electrical/Electro-mechanical with 2+ years of relevant experience in lab failure analysis
• Intermediate computer skills with Microsoft Office tools including Word, Excel, and Outlook
• Ability to collaborate with other team members
• Good verbal and writing skills
• English level Desire 80%

Preferred Qualifications

• 1-2 years experience in similar role
• Experience in Medical Device industry
• Familiarity with SAP and Salesforce

• Familiarity with Post Market requirements and systems
• Please submit Resume in English

Costa Rica-Coyol

Hybrid Roles:

About the role:

Responsible for the efficient management of production resources: equipment, personnel and materials.

Your Responsibilities Include:

• Oversee operations efficiency and standardization.
• Directly responsible for complying with the production plan and the quality of the product, as well as for line personnel.
• Analyze and evaluate process improvements in order to reduce defects and scrap and/or improving yields.
• Follow procedures established for each operation, and keep work areas organized and clean at all times.
• Participate and/or lead problem solving processes, whether due to increasing trends on complaints, defects, scrap, or low productivity, among others.
• Provide feedback to PB IV.
• Support employee-safety oriented initiatives: rotation programs of line personnel, use of safety equipment in the production area, and EH&S awareness programs.
• Support EHS management system: responsible of understand, know and apply EHS policy. Responsible to acknowledge and inform the environmental aspects and health and safety risks relevant to mitigate, reduce and eliminate impact during operations.
• Monitor and update the department´s metrics: Yield, Efficiency, Plan Compliance, RCTIME and Quality.

What we're looking for:

• Bachelor or Licenciature degree in Business Administration, Industrial Engineering or Related Field.
• English Level desired: 70-79%
• Technical Competencies: Problem Solving Methodologies.