דרושים Associate Quality Manager ב-Boston Scientific ב-Ireland, Galway

Job Purpose:

As an experienced Quality Engineer, you will demonstrate commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises a diverse workload to ensure timely completion of critical tasks.
• Plans and executes both daily tasks and long-term projects to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Reviews Complaints’ signals and completes investigations for individual events/ unfavourable trends.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.
• Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&S.
• Completes validations for processes/ test methods in line with requirements and best practices.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
• A minimum of 5+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

To search and apply for open positions, visit:

Job Purpose:

You will demonstrate commitment to the Quality Policy (patient safety and product quality) through your daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises workload to ensure timely completion of critical tasks.
• Plans and executes daily tasks to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
• A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

To search and apply for open positions, visit:

Key Responsibilities:

• Leads, develops, and empowers the Galway Supplier Quality team to deliver exceptional results through coaching, mentoring, and talent development initiatives.
• Serves as the primary representative for Global Supplier Quality at the Galway site, ensuring alignment with global sourcing strategies, corporate objectives and on the Regional Supplier Quality Management team.
• Provides strategic direction on supplier quality programs, driving excellence in supplier performance, compliance, and continuous improvement.
• Builds and sustains strong partnerships with suppliers, internal manufacturing, and cross-functional stakeholders to achieve business and quality goals.
• Maintains accountability for product quality decisions, including the assessment and disposition of non-conforming materials from suppliers.
• Champions a culture of continuous improvement, fostering innovation and operational excellence across supplier quality processes and systems.
• Demonstrates effective change leadership, proactively managing transformation initiatives to strengthen quality performance and supplier collaboration.
• Monitors and reports key supplier quality metrics and trends, implementing data-driven actions to mitigate risk and improve overall supplier capability.
• Acts as a key contributor in supplier audits, escalations, and customer complaint investigations, ensuring timely resolution and systemic corrective actions.
• Promotes an inclusive, entrepreneurial work environment that empowers team members and reinforces Boston Scientific’s vision, values, and commitment to patient safety and quality.
• Drive compliance with Quality Policy and Supplier Quality standards.
• Lead and develop a professional team, set priorities, allocate resources, and establish operating policies.
• Resolve complex technical and organizational issues; develop and implement solutions with broad impact.
• Influence decisions internally and externally; communicate technical information in clear business terms.
• Accountable for business results, project planning, and achievement of SQP-level goals through leadership and mentorship.

Education & Experience:

• Level 8 Honors Bachelor’s Degree in a technical discipline such as Science or Engineering. (STEM)
• Minimum of 8 years’ experience in manufacturing operations, supplier quality, or engineering, including people management and leadership responsibility.
• Proven record of leading teams, with demonstrated ability to build high-performing, inclusive, and accountable organizations.
• Strong technical foundation with, demonstrated logical decision-making focused on product quality and patient safety.
• Demonstrated ability to manage and influence internal and external stakeholders, to drive alignment and commitment

About the role

The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities include:

• Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

what we're looking for in you:

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and/or systems integration

Maximum Salary: $ 197000

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.

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.

Job Purpose:

You will demonstrate commitment to the Quality Policy through your daily execution of sound quality practices and the maintenance of an effective quality system and complying with regulations governing the quality system. You will ensure your team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Key Responsibilities:

• Lead a group or team of employees in the achievement of organizational goals.
• Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Assure that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establish and promote a work environment which supports the Quality Policy and Quality System.
• Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
• Have the responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
• Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
• Be a leader in QSR, ISO / MDD standards within your group, be constantly aware of best industry practices.
• Have significant expertise in validation engineering and be familiar with all regulatory requirements.
• Champion continuous improvement and innovation from a quality perspective within the department.
• Provide technical guidance to Quality Engineer and Quality Technicians.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
• Promote the attainment of group goals by selecting, motivating, and training capable staff.
• Monitor progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
• Provide direction and guidance to experienced professional employees.
• Act as an adviser to professional employees and may become actively involved, as required, to meet schedules and resolve problems.
• Evaluate performance of and assist in career development planning for subordinates.
• Work under minimal supervision. Independently determine and develop approach to solutions.
• Create immediate to mid-range plans to carry out objectives established by top management.
• Interview and recruiting new team members as needed.

Education & Experience:

• A Bachelor Degree Level 8 (240 credits) of Engineering, Sciences or equivalent experience.
• 5-8 years’ Quality Assurance/Engineering experience in the Medial Device / Combination Product (Highly regulated environment)
• Experience with new product introduction and project management is advantageous
• Team player with strong work ethic and positive mentality
• Strong written & verbal communication skills, with excellent stakeholder management.
• Strong technical knowledge & understanding of product design.
• People management experience is advantageous.

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Hybrid Roles:

Your 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.

Minimum Required Qualifications

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• 2+ years of experience as Quality Engineer
• English Level B2 (advanced)

Job Purpose:

As an, you will have the opportunity to work on a range of projects including leading a product or technology development project, moderate-sized Site Transfer / Acquisition projects, and a site representative for broader Global projects as required.

Key Responsibilities:

• Lead medium/large sized cross-functional development teams.
• Provide input to functional managers on the team and team member performance. Influences & satisfies key project stakeholders through each phase of the project.
• Manage the technical challenges of technology application and new product development; proactively identifies, communicates and manages technical risk engaging the key subject matter experts in this process.
• Develop and implement the project plan proactively identifying risks and embedding appropriate mitigations into plans
• Build team ownership and commitment to the project plan outlining clear decision points Presenting options & recommendations to decision-makers supporting data/rationale.
• Develop and control the project budget throughout the project lifecycle.
• Follow the appropriate applicable project roadmap (e.g. PLCP process for NPI, Product Transfer roadmap for Site Transfers etc.) and represent Operations on the overall Core Team; lead the Operations team to complete all activities to current policies and practices & represents same at all phase reviews.
• Responsible for team and cross-functional communications ensuring appropriate communication is maintained throughout the project with key stakeholders and specific issues/decision points are communicated in a timely manner.
• Ensure the communication is tailored for the audience from Project Team reviews right through to Senior Leadership reviews. Lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.

Education & Experience:

• Level 8 Honors Bachelors degree (240 credits) in a Technical discipline (e.g. Engineering, Science, Software, Manufacturing); a Qualification in Project Management and/or a Level 9 (Masters) would be an advantage.
• 5+ years of project management in an Operations or New Product Development environment
• Strong experience in project managing larger-scale / complex projects involving multiple functions (e.g. Divisional R&D, Program Management, Regulatory Affairs, Design Assurance, Process Development, Sustaining Engineering, Global Supply Chain) and/or Multiple Sites (e.g. Global or StAR projects, Strategic Transfers)
• Proven leadership skills in change management and project management.
• Demonstrates excellent verbal and written communications to project team and all stakeholders at multiple levels.
• Must have proven skills in people management, collaboration, influencing and team building.
• Must be proficient with MS Project or similar Project planning tool.
• A formal Project Management qualification or certification is an advantage.
• Strong communication skills across all levels in organization – tailors the message to the audience