Engineer, Sr Quality

hace 1 día

Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

**Engineer, Sr Quality**:

- Remote Eligible: Hybrid- Onsite Location(s): Heredia, CR**Additional Locations**: US-MN-Arden Hills; Costa Rica-Coyol; Costa Rica-Heredia

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**About the role**:
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Primary focus of this role will be the execution of Post Market Reporting assessments (Periodic Safety Update Reports) including but not limited to all associated design control and quality system deliverables related with execution. The role identifies, analyzes, investigates, monitors, and documents trends at a product performance level for post marketing surveillance data. As a Senior Engineer in this space, this role is responsible for leading the analysis, investigation, drawing conclusions and leading divisional partners in assessment and/or execution of potential non-conformances and continuous improvement.

The role will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level to ensure Cardiac Rhythm Management products meet evolving standards in the European Union (EU) and globally. Responsible for identifying and helping with implementing continuous improvements related to product performance and the post market support processes.

Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical/product development projects, continuous improvement projects, sustaining existing product families, or system/services support.

This role provides visibility across site, across division, and with divisional leadership.

**Your responsibilities include**:

- Lead project teams and franchises in the execution of Quality Deliverables including but not limited to Post-Market Surveillance Plan & Report, as well as collaboration on the execution of Clinical Evaluation Reports.
- Act as a lead team member in continuous improvement projects to ensure Post Market Surveillance reports are completed with efficiency and compliance.
- Act as lead team member in analyzing customer complaints, compliance events, clinical data and post marketing surveillance data by examining for patterns, trends and investigating when necessary.
- Act as a team member in relevant Communities of Practice regarding Post Market Surveillance activities with influence across multiple Boston Scientific divisions and departments.
- Lead in the investigation of potential and/or identified trends or data issues with cross-functional teams across division(s).
- Act as key team member in representation for regulatory audits and supporting government agency inquiries, and questions. Provide guidance to assurance compliance to all relevant laws and regulations.
- Provides leadership and mentorship to junior staff; 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 to the Quality Policy and all other documented quality processes and procedures.

**What we’re looking for in you**:

- Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering, related discipline - or relevant experience.
- Minimum of 5-8 years of Medical Device design controls, post market and/or risk management experience required.
- Understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EU MDR, EN ISO 13485, and EN ISO 14971.
- Strong communication (oral and written) and presentation skills.
- Familiar with Microsoft Office Suite, specifically Excel.
- Experience with Quality Planning, Quality System Requirements and standards gap assessment.
- Focus on detailed work with emphasis on accuracy and completeness.
- Eager problem solver capable of driving items to closure and brainstorming areas for improvement.
- Travel approximately 10% of the time.
- Or an equivalent combination of education and experience.

**Requisition ID**:550886

**Jo

  • Engineer, Sr Process

    hace 5 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer, Sr Process**: - Remote Eligible: Onsite- Onsite Location(s): Heredia, H, CR**Additional Location(s)**: Costa Rica-Heredia **About the role**: Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of new product into production. **Your responsibilities...

  • Engineer, Sr Supplier

    hace 2 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer, Sr Supplier**: - Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...

  • Sr Supplier Quality Engineer

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, CR**Additional Locations**: Costa Rica-Heredia**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science...

  • Sr. QA Engineer

    hace 3 días

    Heredia, Costa Rica Moody's A tiempo completo

    The Senior QA Engineer - Salesforce require the competencies of a Sr. QA Engineer in understanding the business requirements and that the developed products meet the design specifications, a Technical QA engineer in creating the test strategy by understanding how technology has been used to address the business use cases, a Automation QA Engineer to...

  • Sr Network Engineer

    hace 1 semana

    Heredia, Costa Rica Softtek A tiempo completo

    **Role: Sr Network Engineer**: - +4 Years supporting enterprise networks - Experience with SDWAN - Experience with Routing and Switching - Experience with Cisco ASA Firewalls - Basic understanding of Networking concepts: OSI and TCP/IP Model, Vlan, QoS - Network analysis and troubleshooting - Basic understanding of networking including SIP, TCP\IP, DNS,...

  • Quality Engineer Assistant

    hace 3 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...

  • Sr Software Engineer .Net/Azure

    hace 7 días

    Heredia, Costa Rica Gft Technologies Se A tiempo completo

    **About the role**:At this role you will be a Sr. Software Engineer (.NET/Azure) who write code, participate in code reviews, evaluate SAST findings, and collaborate closely with other members of the larger Employer Services organization, to deliver high-quality software solutions to our clients and partners.The Sr. Software Engineer (.NET/Azure) will also...

  • Quality Engineer Assistant

    hace 3 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    Responsibilities - Under the direction of Quality / New Product Introduction (NPI) or other technical managerial position and depending on the incumbent´s level of knowledge and Education, he/she will assist the engineers in projects related activities such as: documents preparation, documents translations, component specification, item master creations,...

  • Quality Engineer

    hace 4 días

    Heredia, Costa Rica GRUPO PRESELECCION ELY S.A. A tiempo completo

    **Requisitos**: What You Will Need Bachelor’s Degree in Electrical, Electronic, Industrial Engineering or related Engineering discipline Advanced English level (MUST) Experience of 6 to 8 years as Quality Engineer. Experience using data mining software such as JMP and SPOTFIRE Exposure to Six Sigma and Lean Principals Problem Solving, 8D and FMEA...

  • Quality Engineer Iii

    hace 7 días

    Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Quality Engineer (Process, Systems and Supplier)**Department**: Quality Assurance**Document Purpose**: this document serves as guidance to establish the professional classification in the quality engineering area, defining specific and general activities that require revision on each position to establish the correct scope and...

  • Engineer Ii, Quality

    hace 2 semanas

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**: - Remote Eligible: Onsite- Onsite Location(s): Heredia, H, CR**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...

  • Engineer Ii, Quality

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: Costa Rica-Heredia**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Engineer I, Quality

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer I, Quality**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Sr Data Analytics Engineer

    hace 3 días

    Heredia, Costa Rica Hewlett Packard Enterprise Company A tiempo completo

    Sr Data Analytics Engineer This role has been designed as 'Hybrid' with an expectation that you will work on average 2-3 days per week from an HPE office.Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work.We help companies connect, protect, analyze, and act on their data and applications wherever...

  • Engineer Ii, Quality

    hace 1 día

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer II, Quality**: - Remote Eligible: Hybrid- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and...

  • Engineer, Sr R&d

    hace 2 semanas

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer, Sr R&D**: - Remote Eligible: Hybrid- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and...

  • Quality Engineer

    hace 1 semana

    Heredia, Costa Rica HUBER+SUHNER A tiempo completo

    At HUBER+SUHNER, we design and create essential components that transport power and data through networks. This is how our employees around the globe contribute to a world where people get and stay connected. **Quality Engineer**: **Heredia** | **Full-time** | **Unlimited*** **Your tasks**: - Directly responsible for ensuring all quality standards for...

  • Engineer, Sr Labeling Job

    hace 7 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Engineer, Sr Labeling Job**:- Remote Eligible: Hybrid- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and...

  • Sr Quality Supervisor

    hace 4 días

    Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Sr Quality Supervisor**: - Work mode: Onsite- Onsite Location(s): Heredia, CR**Additional Locations**: Costa Rica-Heredia **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our...

  • Engineer Sr Analyst

    hace 7 días

    Heredia, Costa Rica Citi A tiempo completo

    The Engineer Sr Analyst is responsible for a variety of engineering activities including the design, acquisition and development of hardware, software and network infrastructure in coordination with the Technology team.The overall objective of this role is to ensure quality standards are being met within existing and planned frameworks.Network Build Engineer...