דרושים Qa Quality Supervisor ב-Boston Scientific ב-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

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

Arden Hills, MN Onsite

In this role, you will lead design changes originating from product or yield improvements, Regulatory or supply chain needs. You will develop new technologies, products, materials, processes, or equipment with minimal supervision.

Key Responsibilities:

• Resolves urgent issues effectively, applying engineering knowledge to problem solve and support business in rapidly evolving situations
• Develops technology, product designs, testing of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Leads product improvement design activities
• Designs, coordinates, and analyzes complex engineering tests and experiments.
• Develops slide decks & reports and presents updates to management & technical community.
• Influences middle management on business solutions.
• Interfaces with Marketing and/or field personnel to obtain feedback on concepts and performance of new devices.
• Translates customer needs into product requirements and design specifications.
• Partners with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure success.
• May train and/or provide work direction to technicians and entry-level engineers.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors.
• May lead projects within the function or department and/or represent a specialized field in larger project teams.
• Uses discretion, diplomacy and tact to resolve difficult situations.
• Conducts root cause analysis of design related field complaints
• Support RA team with new markets registrations and regulatory submissions.

Minimum Required Qualifications

• Bachelor’s degree or more from an accredited school in Mechanical or Biomedical engineering or related field
• 7+ years of experience in engineering with a Bachelor’s degree OR 5+ years of work experience in engineering with a Master’s degree
• Experience as a hands-on design and project engineer in the medical device industry, responsible for new implantable device designs, materials, equipment, and processes.
• Hands-on experience utilizing SolidWorks 3D CAD and drafting standards (e.g., ANSI Y14.5)
• Experience executing projects through commercial launch
• Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines.
• Ability to identify and solve problems with root cause analysis, including designing and executing experiments and using statistical methods to drive data-based decisions.
• Willingness to work onsite (4+ days per week) at our Arden Hills, MN site

Preferred Requirements

• Experience designing and evaluating test methods and fixtures.
• Ability to work hands-on with test systems and develop new test systems as needed.
• Working technical knowledge of implantable medical devices.
• Experience with commercialized product data management systems.
• PE licensure preferred; a minimum of EIT certification desirable.

Base Salary Range

Minimum Salary: $ 82600

Maximum Salary: $ 156900

Compensation for
exempt rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.

As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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.

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

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 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