Engineer Sr Qa Complaints jobs at Boston Scientific in Costa Rica, El Amparo

Costa Rica-Coyol

About the role:

Develop, implement, maintain and improve appropriate quality system elements to ensure the high-quality level of new and existing products. Provide guidance and support to NCEP and CAPA owners for documentation, timelines, and eCAPA system use. Provide guidance and support for other day-to-day activities within the department. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your responsibilities include:

• Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Corrective and Preventive Actions (CAPA).

• Collaborate with NCEP and CAPA owners on documentation, timelines, and eCAPA system use, to prioritize tasks and ensure content is clear/well-documented.

• Perform failure analyses and defect investigations as needed. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues and approve material dispositions.

• Perform and/or lead risk analyses and failure investigations for CAPA and/or audit finding investigations. Act as an effective leader of team member in supporting quality disciplines, decisions and practices.

• Create, revise, and approve departmental procedures and quality system records. Lead in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.

• Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.

• Monitor and track the progress of quality-related tasks and initiatives, with a focus on NCEP and CAPA records. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.

Minimum Requirements:

• Bachelor’s degree in engineering, or a related field.

• 3+ years’ experience in the medical device industry with a solid understanding of QSR and ISO 13485 Quality System requirements

• English level B2 or above
• Excellent verbal and written communication skills

• Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)

• Strong technical writing skills and ability to clearly communicate complex information

Preferred qualifications:

• Project/task management experience

• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM)

• Experience with nonconformance and/or CAPA process

Hybrid Roles:

You're Responsibilities include:

• Introduce and advance the Lean culture, principles and practices across the plant and work with local management to create and drive the Lean vision for the plant.
• Initiate and lead improvement projects (i.e. Lean, BPI, VIP) with the Production, Process Development, Manufacturing Engineering, and other support functions.
• Develop and conduct Lean training programs for employees at all levels and departments.
• Create, maintain and refine a Lean toolkit that can include: 5S, Kaizen, Value Stream Mapping, mistake proofing and line balancing.
• Deploy and support the use of corporate Lean tools and Metrics (Core Metrics, 5S, Lean Goals and Plans, etc.).
• Coordinate and lead engineering tasks, which may include: Creating and approving change requests, process optimization assessment, lead improvement project (as directed by site).
• Promote cross-functional and inter-site teamwork to accomplish shared objectives.
• Maintain a general knowledge of current Industrial Engineering trends and methodologies
• May supervise, mentor or provide work direction to other members of the Industrial Engineering team.

What We’re Looking For:

• Bachelor's degree in engineering.
• English Level desired: B2+
• Experience: 7+ years
• Or an equivalent combination of education and experience.

Costa Rica-Coyol

Hybrid Roles:

Your responsibilities include:

• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
• Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.
• Read and interpret technical drawings, procedures, and protocols
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Support environmental monitoring, microbiology and product testing as in approved procedures and protocols.

Required Qualifications:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• 0+ years of related work experience or an equivalent combination of education and work experience
• English language required B2: 70-79

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

Hybrid Roles:

You're Responsibilities include:

• May execute the following resposibilities:Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
• Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.
• Read and interpret technical drawings, procedures, and protocols
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process. 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 Industrial Engineering, Quimical Engineering, Electrical Engineering, Electronic Engineering or any similar
• English Level desired: B2+
• Experience: 2+ years
• Or an equivalent combination of education and experience.
• Desired knowledge: ISO485, Power BI, SAP, MES, Minitab, Non conformance handling

Hybrid Roles:

You're Responsibilities include:

• Introduce and advance the Lean culture, principles and practices across the plant and work with local management to create and drive the Lean vision for the plant.
• Initiate and lead improvement projects (i.e. Lean, BPI, VIP) with the Production, Process Development, Manufacturing Engineering, and other support functions.
• Develop and conduct Lean training programs for employees at all levels and departments.
• Create, maintain and refine a Lean toolkit that can include: 5S, Kaizen, Value Stream Mapping, mistake proofing and line balancing.
• Deploy and support the use of corporate Lean tools and Metrics (Core Metrics, 5S, Lean Goals and Plans, etc.).
• Coordinate and lead engineering tasks, which may include: Creating and approving change requests, process optimization assessment, lead improvement project (as directed by site).
• Promote cross-functional and inter-site teamwork to accomplish shared objectives.
• Maintain a general knowledge of current Industrial Engineering trends and methodologies
• May supervise, mentor or provide work direction to other members of the Industrial Engineering team.

What We’re Looking For:

• Bachelor's degree in engineering.
• English Level desired: B2+
• Experience: 5+ years
• Or an equivalent combination of education and experience.