דרושים Clerk Product Complaint ב-Boston Scientific ב-Costa Rica, El Amparo

Hybrid Roles:

About the role:

Plan, develop and maintain Post Market Surveillance compliance programs, policies, and processes. Create and champion improvement in the application of Quality System. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CISs and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

You're Responsibilities include:

• Recruit, coach and develop organizational talent.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Work cross-functionally to identify and resolve issues.
• Determine appropriate staff levels, schedules and resources.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

What We’re Looking For:

• Bachelor's degree in Engineering
• English Level desired: B2+
• Experience: 10+ years
• Or an equivalent combination of education and experience.

Hybrid Roles:

About This Role:

As a part of the Global Systems & Processes team, the Sr Product Analyst will maintain and enhance global systems and processes to support quality goals and priorities for the Post Market Quality organization. This role is responsible for developing, establishing, and maintaining quality methodologies, systems, and practices to meet BSC, customer, and regulatory requirements. This individual will partner with stakeholders to recommend, design, and implement functional and technical process and system improvements, while enabling solutions that deliver valued business outcomes for Boston Scientific.

Your Responsibilities will Include:

• Partnering with an IT development team to support the launch and implementation of new system functionality; solicit business requirements, create user stories, and facilitate User Acceptance Testing (UAT)
• Performing qualitative and quantitative data analysis, opportunity assessments, and product experiments
• Analyzing and prioritizing requirements as a part of the overall Product Backlog
• Creating and publishing resources and information for the Post Market Quality organization
• Communicating process changes to users; developing and delivering user training and awareness sessions, as well as other global communications
• Providing support for the Post Market Quality organization to ensure defined quality goals and objectives are met
• Leading and participating in large-scale cross-functional, high-impact projects

Required Qualifications

• Bachelor's degree in any discipline with at least 6 years related work experience
• English Level: B2+: 80-89%
• Medical device quality experience
• Experience with system management, process analysis and development
• Experience with change management
• Proficient with Microsoft Office Suite and SharePoint
• Ability to travel globally, up to 15%

Preferred Qualifications

Note:Work samples will be requested as a part of the hiring process for this role.

• Ability to communicate effectively with individuals on all levels (written and verbally)
• Strong technical acumen with ability to collect, analyze and interpret business information and translate business needs into technical solutions
• Ability to work in a self-directed, fast-paced environment and complete work without significant guidance
• Strong problem-solving capabilities, high sense of urgency, and commitment to execution
• Ability to remain flexible and adaptable to changing needs and priorities
• Experience with Product Teams, Agile Scrum and Kanban methodologies
• Experience with Jira, Salesforce, Power BI or Tableau, SharePoint, Adobe Premiere, and/or Digital Adoption (Whatfix) software

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

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