דרושים Senior Supplier Quality Manager Ii 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:

As a Microbiologist II you will conduct data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Key Responsibilities:

• Demonstrate a primary commitment to patient safety and product quality.
• Responsible for maintaining a full understanding and complying with all the regulations governing the quality system (including ISO 17025).
• Ensure all training is completed as per Laboratory Training Program 90188455.
• Co-ordinate and train to ensure compliance to mandatory training requirements.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Provide technical guidance/trouble shooting in the event of Microbiology related issues.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Provide direction to Technician roles and various operations workstreams.
• Attend and represent the Microbiology Laboratory at various meetings and on cross functional project teams as required.
• Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner.
• Designee for Laboratory Supervisor as required, by overseeing the day to day operation of the Microbiology laboratory.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• Perform and assist with additional duties as may be directed by the Microbiology supervisor/Manager.
• Compile, Review and Report Environmental metrics; Calculate and review product bioburden alert limits and cleanroom air and surface alert and action limits; Establishes and monitors appropriate Lab Metrics including Management Review support; Review and Assess from a microbiology context all changes that impact product or the cleanroom environment including introduction of new products; Provides technical support on microbiology related issues to various operational departments.

Education & Experience:

• Level 8 Honours Degree in Microbiology or a related Science based discipline.
• 3+ years experience post-graduate in a Regulated Environment

Job Purpose:

As a Senior R&D Engineer, you will be responsible for providing
electrical and electronic engineering support and expertise in the definition, design, development and test of medical device products with a particular emphasis on catheter-based ablative therapies such as Renal Denervation (RDN).

This is a leading role in design and troubleshooting of mixed hardware/software systems associated with SUD devices, ensuring compliance with regulatory and safety standards, and contributes to innovation and intellectual property development, enabling safe, effective, and differentiated therapy delivery systems.

Key Resposponsibilities:

• Designs, develops, debugs, modifies, tests electrical circuits and systems for therapeutic ablation catheters and consoles, using current tools, analysis techniques, and technologies.
• Leads troubleshooting and root cause analysis of electronic test failures, driving solutions to component/system level.
• Develops, tests, and characterizes new catheter prototypes and console interfaces from concept through launch in cross-functional teams.
• Analyzes, evaluates, and verifies requirements, circuits, and systems using engineering practices; ensures integration of hardware, firmware, and physiological signal acquisition.
• Investigates, researches, and selects electronic circuits, components, tools, equipment, and practices for advanced ablative therapy devices.
• Documents electrical development through protocols, technical reports, memos, change requests, and design history files, per BSC quality system standards.
• Ensures compliance with medical device safety and EMC standards (e.g., IEC60601 series).
• Mentor junior engineers and technicians; provides technical leadership, feedback, and training to build high-performance teams.
• Translates high-level clinical requirements into robust engineering solutions and identifies opportunities for product innovation and intellectual property.
• Communicates technical updates at weekly team meetings, risks, and milestones to project leaders and senior stakeholders
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained 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.

Required:

• Level 8 Honours Bachelor Degree in Electrical Engineering.
• 5+ years of experience in medical devices or other highly regulated industries, preferably with catheter-based or implantable systems.
• Hands-on expertise in circuit/system design, system troubleshooting, and root cause analysis.
• Proven experience with regulatory/safety standards (IEC60601 series, EMC).
• Strong communication, documentation, and project management skills.

Preferred:

• Experience with ablative modalities (RF, ultrasound, IVL, PFA).
• Familiarity with firmware debugging, digital logic, FPGA, and system integration.
• Data analysis (LabVIEW, MATLAB, Python) and automated test development.
• Experience in intellectual property development (patent drafting, disclosures).
• Demonstrated ability to mentor and lead cross-functional teams.