Sr Quality Manager jobs at Boston Scientific in Costa Rica

Hybrid Roles:

About the role:

This position operates during night shift hours, supervising Engineering and/or Technician activities that directly or indirectly support production operations or test laboratories. Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Identifies, coordinates, and assigns project priorities based on business and department objectives. Ensures implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

You're Responsibilities include:

• Oversees daily functions and work flow to meet operational objectives, comply with all policies and procedures, assure safety, and achieve effective core metrics performance.

• Supervises the management of staff, including workforce planning, recruitment, shift schedules, skill and performance assessments, workload distribution, training, corrective action, recognition, and daily direction on work assignments and priorities.

• Identifies and resolves operational issues and manages addressing non-conformance matters. Recommends and implements process improvements.

• Serves as internal liaison for team operations, including preparing reports and presentations on functions and performance.

• Ensures that special projects are completed following established schedules and procedures. Interfaces with cross-functional teams on special projects.

• Performs other responsibilities as required.

What We’re Looking For:

• Bachelor’s degree in engineering (ie: materials, chemical, industrial or similar) could be in process.

• English Level desired: Intermediate.

• Experience: 3 years and 1 year in Incoming areas as coordinator or area lead.

• Or an equivalent combination of education and experience.

Desired knowledge

Technical & Quality Systems Knowledge

• SAP Quality Module: Deep understanding of inspection planning, material master data, and quality notifications.

• CAPA & Non-Conformity Management: Root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram), CAPA effectiveness checks.

• Validation Protocols: IQ/OQ/PQ processes, statistical tools for correlation studies, GAMP 5 principles.

• Measurement Systems Analysis (MSA): Gauge R&R, calibration techniques, and metrology fundamentals.

• Document Control Systems: Proficiency in Agile, Trackwise, and document lifecycle management.

Operational & Strategic Skills

• Area Metrics & KPI Development: Designing dashboards, trend analysis, and continuous improvement tracking.

• Lean Six Sigma: Application of DMAIC, waste reduction, and process optimization.

• Purchasing & Budgeting: Vendor evaluation, cost-benefit analysis, and procurement processes for lab equipment.

• Payroll & Personnel Management: Basic HR systems knowledge, timekeeping, and performance evaluation.

Leadership & Training

• : Conflict resolution, delegation, and performance coaching.

• Training Program Development: Creating competency matrices, onboarding plans, and technical training materials.

Regulatory & Compliance Knowledge

• ISO 13485 / FDA 21 CFR Part 820: Understanding of medical device regulations and audit readiness.

• Risk Management: FMEA, hazard analysis, and risk mitigation strategies.
• Document Creation (WI/SOP): Writing clear, compliant procedures and work instructions.

Your Responsibilities Include:

• Works with the corresponding functional and project managers to define project scope, strategy, timeline and budget associated.
• Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Assures project quality by using standard development methodologies and by working with the corresponding Quality representatives to develop and execute project quality plans.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.Resolves project issues by working with team members, project customers, and others as appropriate.
• Monitors and controls projects deliverables, and assures projects success through monitoring activities verifying activities completion and effectiveness.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What We’re Looking For:

• Licenciature degree in Business Administration, Engineering or related.
• English Level: C1:(90-94%).
• Desired knowledge: certificacions (PMP, SCRUM, PgPM, PMI-ACP, PMI-RMP, PMI-SP), MS Office, MS Project, Planning, Execution, Problem Solving, Triple Constraint Management, Risk Management, Capex Management.
• At least 7 years of experience in similar position.

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

Key Responsibilities

• Lead strategic planning with senior executives to develop a comprehensive business strategy for Costa Rica and Central America, including market mapping and opportunity identification.
• Develop and execute integrated marketing plans to maximize market share, promote new product launches, and build brand awareness and customer loyalty.
• Conduct ongoing market research and competitor analysis to identify new opportunities and monitor market shifts.
• Collect and structure field information for updated market mapping and business sizing.
• Initiate and lead customer programs, networks, and advisory boards.
• Manage and oversee the regional marketing plan and budget.
• Lead and manage new product launches.
• Design and implement conference and symposium strategies to support the regional plan.
• Collaborate with sales managers to ensure sales representatives are adequately trained; organize physician and staff training, patient education events, and monitor post-training results.
• Select, develop, motivate, and retain a high-performing marketing team.
• Work with operations to manage supply chain for products, including forecasting, backorder management, and inventory planning for new products.
• Develop clinical activities plans, including registries and post-market studies.
• Quantify and prioritize reimbursement opportunities and execute related plans.
• Spend approximately 50% of time in the field supporting account conversion, product launches, clinical activities, and market intelligence gathering.
• Maintain regular communication with international/corporate marketing and sales/country management to ensure alignment.
• Ensure alignment with international functions (Finance, Supply Chain, Health Economics, Marketing, Clinical, Regulatory, Quality).
• Ensure compliance with standard operating procedures and champion quality and regulatory commitments.
• Promote quality awareness and guide the organization toward improved performance and customer-oriented initiatives.

What we are looking for in you:

• Bachelor’s degree in Marketing, Business Administration, or a related field.
• Fluent English.
• Experience working in sales organizations. (preferably in medical devices)
• Proven marketing and leadership experience of 5 or more years.
• Thorough practical knowledge of marketing theories, principles, and systems.
• Experience applying business and industry standards to achieve objectives.
• Strong problem-solving skills and ability to adapt plans to meet business challenges.
• Effective decision-making impacting finances, results, and service levels.
• Excellent communication and collaboration skills, with the ability to influence and guide others.

Our Graduate Programme is designed to accelerate your professional development and provide you with extensive experience within Boston Scientific Clonmel. Throughout the 23 month programme, you will be provided with dedicated mentors and will have professional development 1:1 meetings to provide you with a solid foundation for a successful career. Our Graduate Programme is created around hiring the most innovative and best individuals, while Boston Scientific Clonmel provides the means for you to continuously learn and enhance your skill set to drive your career growth.

Responsibilities

• Works as part of the Global Team to assist in creation and monitoring of project plans, communication and documentation of ways of working (standard processes).
• Works on the Global Implementation of a new Enterprise Resource Planning (ERP) tool SAP S4 HANA.
• Works in the JIRA system to update data on project progress
• Works using Agile & Waterfall project management tools
• Conducts her/ himself as a regular full-time member of the staff by accepting and adhering to Boston Scientific's rules and regulations and by engaging in professional and personable conduct at all times with staff and customers. The intern is also obligated to comply with any confidentiality and professional policies established by the Boston Scientific.
• Becomes knowledgeable about her or his own responsibilities and the business and operational issues inherent in them as well as about the Boston Scientific's management and particular issues relevant to the Company.
• Contributes to the preparation and production of proposals and reports by using word processing, spreadsheets, and other computer programs.

Required

• BSc degree (Honours) in relevant discipline essential.
• Must have graduated within the last two years or in final year of University
• Relevant work experience/ co-op programme completed.
• Eligible to work in IrelandCommunication Skills
• Project Management Skills

** 23 Month Contract ** Closing Date 27th November

Should you require a reasonable accommodation during the recruitment process or after if offered, please let us know.

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