דרושים Microbiologist Ii ב-Boston Scientific ב-Ireland, Galway

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

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

Advancing possibilities for a brighter tomorrow

Advises and guides the company and demonstrates leadership on EHS matters to ensure the safety and health of the workforce, and the protection of the environment. Ensures the company is aware of, and complies with applicable environmental, health and safety legislative and other requirements.

Key Responsibilities

• Support and improve the Health and Safety Management System. Participate in audits of the Management System on a scheduled basis.
• Stay informed of current and new Health and Safety regulatory requirements and other guidelines considered for implementation.
• Maintain plant statistics, performance to goals and other records necessary to maintain the EH&S Management System status and comply with regulatory requirements.
• Represent Boston Scientific to outside parties, such as regulatory agencies.
• Maintain metrics for assessing EH&S effectiveness.
• Works with Supervisors, Trainers and Technicians to identify and control significant environmental, health and safety impacts of operations.
• Ensures that all required records are prepared and maintained.
• Participates in and prepares for EHS inspections by external agencies, and all system audits.
• Investigates, prepares, communicates and manages reports on incidents, injuries, ill-health, and corrective actions as required.
• Conducts risk assessments including ergonomic evaluations.
• Maintains and updates SDS’s and chemical inventories.
• Supports and contributes to the site’s life safety programs to include emergency response.
• Understands and proactively follow through on the Health and Safety Management Procedures that have been identified as relevant to position.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personal, 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.

Educational Requirements & Skills

• Level 8 qualification in Health & Safety.
• Requires in-depth conceptual, practical and technical and/or functional knowledge of principles and theories in own job function and general understanding of related job functions
• Has experience in applying this knowledge in a variety of situations to accomplish work
• Applies understanding of key business drivers in the context of the organization's industry and how closely related teams integrate with others to accomplish their objectives and drive efficiencies
• Supports team members by setting an example, coaching and providing feedback and guidance
• May lead safety projects or project steps with manageable risks and resource requirements
• Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy to propose alternatives to understanding their impact on the business or apply judgment based on experience to develop new solutions
• Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems
• Impacts quality and effectiveness of customer, operational, project/program or service activities within own team and other related teams
• Exerts some influence on the overall objectives and long-range goals of the organization
• Exchanges complex information with others, potentially guiding and persuading others
• Regularly participates in discussions and presentations in small, cross-functional meetings, logically presenting information to convey key messages.

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Key Responsibilities:

• Ownership of the execution of complaint approvals within the BSC Global Complaints Management System which includes a comprehensive review of Complaint Investigations to ensure they meet regulatory and BSC requirements.
• Ownership of the execution of complaint investigations within the BSC Global Complaints Management System which includes execution of insightful laboratory testing on returned complaint devices, where required.
• Complaint event root cause analysis and determining investigation pathways and any actions to be taken.
• Using data analytics tools to monitor product performance and investigation process performance.
• Preparation and provision of complaint trend data and sharing of data and trend analysis at review forums.
• Drives continuous improvement initiatives to investigation methodology and associated processes and lead applicable projects of improvement.
• Make decisions and determine escalation pathways, as well as demonstrating ability to work on one’s own initiative and with minimum supervision is required.
• Understands and complies with all the regulations governing the quality systems.
• Development and maintenance of collaboratively relationships within the Galway investigation team, and with other investigation and complaint management centre teams across the global Post Market Quality Assurance function.
• Development and maintenance of partnerships with Quality Operations, Design Assurance, Field Support and R&D for the execution of insightful investigations and to support product performance improvements.

Education & Experience:

• Level 8 Bachelors Degree in a STEM subject with a min. of 2-3 years relevant work experience.
• Demonstration of problem solving, process improvement and/or project management skillsets and application.
• Demonstration of taking initiative to drive improvement and change.
• Knowledge on product design, manufacture, functionality and/or clinical use environment. Experience of product design or manufacturing would be an advantage.
• Good technical capabilities, communication skills and organisation skills. Ability to analyse data to gain insights and to share information effectively.
• Proven ability to work well with teams but also with minimum supervision.
• Experience of Angiographic image review experience would be an advantage.
• Hepatitis B Vaccinations course required to work with returned decontaminated product.

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Job Purpose:

As an R&D II you will work as part of the Galway Peripheral Interventions (PI) R&D Team and will provide support to a series of products and projects in Develop, Optimize & Maintenance Phase of Product Development. Will provide design solution and technical support to ensure safety, compliance and manufacturing continuity of our product portfolio which includes Balloon Catheters, Stent Delivery Systems, Cutting Balloons and Drug Coated devices. A key team member that, under limited supervision/guidance, compiles, analyses, and reports operational, test, and research data. Will establish/verify performance standards for products, processes, materials and will create/maintain design-related technical documentation and design history.

Key Responsibilities:

• Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, product design changes & troubleshooting, test method development & validation, testing & characterization of materials, development & assessment of specifications, research investigations, data analysis, report preparation etc,
• Responsible for design related documentation including EDS Package, prints and specifications.
• Demonstrates design control & PLCP knowledge through generation of high-quality deliverables.
• Use of design change process to ensure proposed changes are systematically and thoroughly analysed before beginning the change process.
• Maintain product performance through Quality Investigations and ensuring rigorous support for design changes.
• Designs and coordinates product testing and experiments. Summarizes, analyses and draws conclusions from test results.
• Performs troubleshooting on products/process problems as related to design, material or process.
• Prepares standard reports/documentation to communicate results to technical community.
• Interpret evolving global regulatory and standard requirements and assess impact to product design
• Works cross-functionally & cross-site with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
• Work collaboratively with manufacturing to reduce product costs through design improvements.
• Interfaces with vendors and physicians where projects require.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Works under minimal direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpreting established policies, procedures and practices.
• May train and/or provide work direction to technicians and interns.
• Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organisation.
• Demonstrates a primary commitment to patient safety and product quality.

Education & Experience:

• Level 8 qualification required in a relevant discipline including Biomedical, Mechanical, Polymers & Materials.

• 5+ years industry experience within a regulated industry environment and with a track record of accomplishments.
• R&D/technical experience in the medical device industry essential.
• Experience in a PDP and/or Sustaining/Post-Commercial Support role an advantage.
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical & problem-solving skills.
• Knowledge of stent processing & design an advantage e.g. nitinol, stainless steel, laser cutting, braiding, passivation etc.
• Knowledge of polymers & materials characterization, extrusions, moulding & coatings an advantage.
• Experience with rapid prototyping, product concepts, ideation an advantage.
• Demonstrated ability to work with key stakeholders across the globe.
• Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines to schedule

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Function:Quality Pre & Post

Reporting to:Associate Quality Manager

Closing Date:18th April 2025

Days

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. Quality Pre and Post is a sub-group of the site Quality Systems team that supports all material inbound and outbound activities including product release.

Key Responsibilities:

• To provide assistance and support to the Quality Pre&Post function.
• Ensure compliance to all applicable regulatory standards, current GMP procedures and practices
• Review and update of documentation.
• Control of non-conforming product.
• Compile metrics and report results as required to key stakeholders
• Problem solving and continuous improvement investigations.
• To provide assistance and support to the Quality Engineering and Operations function.
• Provision of excellent service to all internal customers for the production group or functional area in which they work.
• Work with Boston Scientific systems including but not limited to eCAPA, MES, SAP, Windchill.
• Communicate any concerns about work process regarding environmental impact, health or safety issues to their Manager
• Raise Quality Catches & implement Mitigations
• Participate in safety walks
• Audit preparation activities

Education & Experience:

• NFQ Higher Certificate Level 6 (120 Credits) or above in STEM Discipline
• Must have 2-4 year experience in a similar role. Medical Device experience is advantageous
• Continuous improvement mindset with a passion for Quality
• Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision
• Good interpersonal skills and organisational skills
• Excellent attention to detail

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