דרושים Sr Supplier Qa Eng ב-Boston Scientific ב-קוסטה ריקה

Hybrid Roles:

About the Role:

The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.

Your Responsibilities Include:

• Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.
• Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.
• Plan, coordinate and execute projects oriented towards in process defects prevention.
• Design and implement process control strategies.
• Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
• Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.
• Provide technical support to the In Process Quality area and to other departments.
• Deliver training related to quality technologies.
• Coordinate with Corporation the implementation of projects related to the In Process Quality area.
• Create new procedures on In Process Quality and/or improve the existing in order to facilitate and assure regulatory compliance.
• Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.
• Participate as a core team member in the new products transfer process, representing Quality Assurance areas.
• May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.
• May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.
• Participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.
• May provide guidance and supervision to process validation areas, software validation complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and/or design assurance.

What We’re Looking For:

• Licenciature degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or Field Related.
• English Level desired:90-94%.
• At least 10 years of experience in similar position.
• Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.

Benefits • Life-Work Integration • Community • Career Growth

Work Mode:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in BSC Arbor Lakes, MN or Marlborough, MA.

Your responsibilities will include:

• Responsible for the development, in collaboration with the clinical trial team, of study-specific documents such as clinical protocol, clinical study reports and summaries, and clinical content that support the regulatory needs of a project.
• Reviews statistical output from BSC clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
• Responsible for the development, dissemination, and amplification of scientific clinical content in a variety of communication vehicles to ensure appropriate evaluation and presentation of data, interpretation, and alliance with business objectives.
• Writes manuscripts, as well as abstracts, slide presentations, and poster presentations for scientific meetings within and outside the U.S. in support of ICTx studies.
• Partners with internal and external authors (physicians/trial investigators) on manuscripts, conference abstracts, slide presentations and posters.
• Identifies gaps and opportunities for compelling evidence for relevant BSC products and therapies. Works with clinical and other functions (HEMA, R&D, marketing, etc) to identify solutions to the evidence gaps identified.
• Helps to organize and chair BSC study publication plan teams. Partners with investigators and internal BSC personnel to solicit feedback and develop clinical study-related publication plans. Serve as an advisor and expert for physicians needing to access relevant clinical content.
• Collaborates and provides input into clinical evidence strategy related to relevant BSC therapies.
• Interacts with marketing and other groups such as Scientific Communications to ensure that clinical data is represented accurately and correctly in any published literature, slide sets, and other materials prepared by these groups.
• Remains current with medical and scientific developments and publications on current/pipeline and competitor products, as well as maintaining a solid knowledge base of current data in relevant fields.
• Attends scientific conferences and programs in relevant therapeutic areas to maintain current knowledge.

Required qualifications:

• Minimum bachelor’s degree is required; and a minimum 3 years of experience (medical device, pharmaceutical, or biotechnology) in a related function such as clinical, research, marketing, medical affairs or product development or equivalent experience
• Proven knowledge of clinical issues associated with cardiology (structural heart, coronary therapies, and/or interventional heart failure) gained through direct or comparable relevant experience in a therapeutic area, scientific, or clinical setting
• Willingness to travel up to 10% travel domestic and international

Preferred qualifications:

• Solid understanding of scientific or clinical research and the scientific method, including interpretation of statistical results of clinical studies
• Demonstrated scientific/medical writing acumen (e.g., manuscripts, research grants, etc.)
• Ability to prepare and deliver scientific presentations, understanding of the structure and content of scientific presentations, ability to tailor presentation format and content to specific needs of topic and/or audience
• Knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

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

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

Costa Rica-Heredia

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

What we're looking for:

• Bachelor or Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• Experience: At least 5 years
• English Level desired: 70-79%
• Technical Competencies: ASQ Certified, Problem Solving, Networking

Benefits • Life-Work Integration • Community • Career Growth

About the Role

As the technical and operational leader, you will play a pivotal role in ensuring manufacturing excellence through continuous improvement, systems integration, and advanced troubleshooting. You will be responsible for sustaining process reliability, leading cross-functional teams, and guiding engineering excellence in a high-impact, regulated environment.

Key Responsibilities

· Lead sustaining activities for a complex, mission-critical manufacturing line with a focus on quality, delivery, and compliance.

· Serve as technical authority on integrated systems including PIMS, MES, Power BI, and PLC-based controls (e.g., Allen-Bradley, Siemens).

· Oversee and drive root cause investigations, implement corrective and preventive actions (CAPA), and lead structured problem-solving using DMAIC, 8D, and other lean tools.

· Manage real-time data analytics and reporting using Power BI dashboards, integrating information from MES and other manufacturing systems.

· Own and drive process validations (IQ/OQ/PQ) and ensure regulatory compliance in alignment with BSC Global SOPs and medical device standards.

· Collaborate with cross-functional stakeholders in R&D, Quality, Regulatory, and Supply Chain to resolve technical challenges and optimize line performance.

· Coordinate equipment troubleshooting and optimization, focusing on PLC signal interpretation and system interlocks to ensure seamless automation.

· Lead and mentor a high-performing sustaining engineering team, promoting a culture of technical excellence, ownership, and continuous improvement.

Qualifications

· Bachelor’s degree in mechanical, Electromechanical, Electronic, or Industrial Engineering.

· 5+ years of experience in manufacturing engineering in regulated industries (medical devices strongly preferred).

· Demonstrated success in leading product transfers and sustaining high-impact lines.

· Proficiency in PLC programming and troubleshooting (Allen-Bradley, Siemens).

· Deep understanding of MES/PIMS integration, with capability to leverage Power BI for advanced manufacturing analytics.

· Advanced knowledge of statistical analysis, process improvement, and validation (DOE, Six Sigma, Minitab).

· Strong communication and leadership abilities for cross-site coordination.

· Fluent in English C1+ (90%+).

· Master’s degree in engineering or related field.

· Six Sigma Black Belt Certification.

· Experience navigating SOPs for quality, transfers, and regulatory compliance.

· Take ownership of a strategically critical product with real-world impact.

· Be at the forefront of systems integration, digital manufacturing, and automation.

· Collaborate across global teams and mentor future engineering leaders.

· Work in a state-of-the-art facility with the opportunity to shape the technical roadmap for high-volume, high-quality production.

Your responsibilities include:

• Sells products by scheduling sales calls to meet with current and potential customers to fulfill revenue and unit growth objectives assigned by company on a monthly/quarterly/annual basis.
• Develops and implements sales strategies by determining the relevant factors (e.g., product, competition and pricing needs) of existing and potential accounts to effectively promote the company's products to appropriate hospital personnel and physicians.
• Develops action plans (i.e., weekly, quarterly, monthly) by analyzing quarterly and monthly sales figures and reports identifying the needs of particular accounts and discussing issues with Regional Sales Manager to help the organization achieve its annual sales goals.
• Determines the needs (e.g., product and pricing), goals, product usage, and types of cases handled by specific customers by meeting with and asking in-depth questions of physicians and other hospital personnel to learn which BSC products can best address their specific needs.
• Observes actual procedures in the lab and operating room of hospital accounts to gain insight into the specific nuances of each physician and each member of the lab staff.
• Establishes pricing packages by working with relevant BSC personnel to establish price points that address specific customer's needs while satisfying company guidelines and policies.
• Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g. clinical research, pricing and/or marketing) to develop optimal solutions.
• Develops relationships with hospital personnel (e.g. through casual conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and to identify key purchasing decision makers in order to facilitate future sales.
• Managing clinicals throughout cases and across different territories.
• Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to secure purchasing commitments, often with the help of incentive programs and services made available to the account being developed.

Required Qualifications

• Minimum of 5 years of experience or equivalent combination of sales and education experience
• Minimum 2 years previous experience in medical device sales

Preferred Qualifications

• A four-year degree with a background in sales and proven track record of success will help in making this position a successful team approach to selling in the radiology lab and to our physicians.
• Strong clinical, analytical and selling skills.
• Person should have a proven ability to take on a large number of accounts.
• Problem solving and the ability to be coached and directed by other teammates will allow collaboration and success in selling the venous and arterial portfolio.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

The Prosthetic Urology franchise is developing a transformational product in the Erectile Restoration space and needs an experienced Senior Global Product Manager to help drive this innovative product to market. This role will encompass both upstream and downstream responsibilities, working collaboratively with partners from our Cardiac Rhythm Management and Neuromodulation divisions to deliver this new technology to market.

Your responsibilities will include:

• Workstream lead for large-scale Product Development Process (PDP) team driving Voice of Customer (VOC) throughout the PDP to ensure user needs are incorporated in every phase of the project
• Collaborate with upstream and downstream cross-functional partners. Work closely with R&D, Clinical, Brand Activation, Medical Education, Medical Affairs, Customer Service and Sales to ensure alignment and successful execution of a clinical trial and subsequent launch plan.
• Support usability efforts in conjunction with cross-functional counterparts and create training content for physicians and patients, including digital user interface content development
• Develop and maintain strong relationships with key customers and KOLs and build credibility with key internal cross-functional stakeholders
• Anticipate challenges and roadblocks before they arise, escalate for support in a timely manner
• Monitor the market landscape to identify market trends, opportunities, and threats. Use this information to inform marketing strategies and product positioning.
• Use classic marketing capabilities: market understanding, market segmentation, product positioning, message development, channel identification, tool and communication creation and execution to further business objectives

Required qualifications:

• Bachelor’s degree in Marketing, Engineering, Science, or related Healthcare/Biomedical fields
• A minimum of 5 years of professional experience in the medical device industry
• Experience launching products with clinical trial requirements
• Proficiency creating impactful marketing plans and supporting product development efforts with a cross-functional team
• Demonstrated ability to manage multiple priorities simultaneously, to influence key stakeholders without direct authority and to tailor communication appropriately based on audience
• Strong analytical, quantitative, and strategic thinking skills
• Flexibility to travel up to 25% in support of tradeshows, internal meetings and customer programs as required

Preferred qualifications:

• Advanced degree (i.e. MBA)
• Class III active implantable medical device experience with ongoing service or support needs post implant
• Demonstrated ability to work independently and collaboratively to meet deadlines and manage all aspects of product development with a high degree of attention to detail

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

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

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

About the role:

• Provide support in the maintenance of the Quality Management System.
• Monitor the proper updating of standard operating procedures (SOPs).
• Promote the management principles of the Quality Management System.
• Promote good documentation and data integrity practices.
• Collaborate with the proper storage of Quality Management System documentation.
• Provide support for the information consolidation process for various purposes: meetings, monthly reports, presentations, management indicators, etc.
• Participate in the continuous improvement process, supporting simplification projects, quality culture campaigns, and proactively seeking improvement opportunities for our Quality Management System.
• Propose and develop automation of process tasks
• This role focuses on Quality support, with a wide variety of tasks.

Required qualifications:

• English Intermediate (B1) minimum, Upper Intermediate (B2) preferred.
• Student in Pharmaceutical, Chemical, Biotechnology, Biomedical, Industrial Engineering or related.
• Good organizational skills and being able to follow established processes.
• Outstanding interpersonal skills and excellent verbal and written communication skills.
• Attention to detail and thoroughness.
• We appreciate individuals who are relentless and persistent.
• Problem Solving
• Root Cause Analysis
• Planning and Organization

Preferred qualifications:

• Prior experience in a similar internship is not required, but would add to the qualifications.
• Data management in Excel (Pivot tables, macros, reports)
• Knowledge about the local regulations (policies) applicable to the health and the medical device industry