דרושים Quality Eng - P2 ב-Boston Scientific ב-אירלנד

Key Responsibilities:

• The ability to perform failure analysis on electronic test failures to get to root cause to component level for implantable electronic medical devices.
• Using knowledge of standard test software applications, able to work with in-house and external software developers to define and drive improvements and changes to test software applications and systems to improve test yields.
• Work with cross functional groups to improve product quality, lean efficiency’s and test system efficiency’s and reduction in production fallout.
• Performs tests, analyzes data, writes reports and executes validations to medical device standards.
• Excellent data analysis and technical problem-solving skills, utilizing common applications and in-house component and device tracking systems.
• Utilizing good documentation skills complete regulatory submissions using change notice process and procedures.
• Work daily with quality, manufacturing engineering and operations, providing improvement feedback and assisting with resolution of quality and manufacturing issues.

Education & Experience:

• Hons bachelors degree in electrical or electronic engineering or related discipline.
• Minimum of 3 year’s relevant experience.
• Experience in an electronics engineering environment.
• Excellent knowledge in electronics with proven problem-solving abilities and the ability to project manage issues to closure.
• Knowledge of test software applications such as Lab View and C or C++
• Experience in validations in the medical device industry would be an advantage.
• Very strong communication skills are a key requirement.

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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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Purpose Statement:

Provide Quality Engineering support to Boston Scientific Clonmel Neuromodulation Implantable Pulse Generator commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. Partner with product development teams to provide quality engineering support and help ensure development of highest quality new products. This position requires interactions with multiple value streams and may also require interactions with multiple divisions across Boston Scientific.

Key Roles & Responsibilities:

• Quality lead on value stream and quality & cost process improvement projects.
• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventive actions.
• Lead on Preventive Quality initiatives in value stream. Driving & participating in WSVA program to support the Production Area Strategy.
• Collaborate cross functionally with local and divisional team members on assigned projects to ensure quality compliance.
• Identify & lead quality projects to support production unit area strategy.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using Engineering Essentials. Investigates and analyse customer/internal complaints.
• Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes (PFMEA, Risk reduction, process change analysis).
• Ensure that corrective and preventive measures meet acceptable reliability standards. Analyse preliminary plans and develop reliable engineering programs to achieve company, customer, and governmental agency reliability objectives.
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Education & Experience:

• Honours Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 2 years’ experience in a Medical Device environment or related industry.
• Demonstrate strong leadership & communication skills and promote quality at source.
• Strong Project Management skills combined with proven consistent execution within committed quality, time, and cost targets.
• Experience/training in problem solving and process improvement methodologies (Engineering Essentials).

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Key Roles & Responsibilities:

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
• Responsible for the final Process Monitor Release for products prior to distribution.

Required Qualifications:

• 2-5 years’ experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline.
• Excellent written and verbal communication skills
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Ability to rapidly learn and use new applications

Preferred Qualifications:

• Previous experience in a Quality, or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
• Experience in problem solving and process improvement methodologies.
• Process Validation, Risk Management, CAPA experience.

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This position is for a 23 month contract

Purpose Statement

Leads team of Quality Engineers and Quality Engineering activities that directly or indirectly support production operations and new product introduction. Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Ensures implementation of assurances, process controls, and CAPA systems designed to meet and exceed internal and external requirements.

Key Responsibilities

• Lead team of Quality Engineers to provide direction, coaching, and mentoring and provide guidance on daily work priorities and sequence of activities in area of responsibility.
• Is an effective people manager resulting in a motivated high performing team and is fully motivated to achieve and demonstrate best practices in line with departmental and Strategic Quality objectives.
• Responsible for performing performance appraisals, for all reporting staff.
• Co-ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shut down periods.
• Responsible for ensuring the department operates within in a set budget.
• Mentor for technical guidance in identifying and resolving quality issues using six sigma, lean, mistake proofing, and related tools/techniques.
• Ensures all direct reports 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.
• Understands, Maintains and implements quality engineering systems and practices to meet BSC, customer and regulatory requirements.
• Serves as a quality representative for the department in all internal / external Audits as functional expert.
• Develops, maintains, and communicates metrics to drive continuous quality and efficiency through the department.
• Leads and participates in customer complaint investigations.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel as appropriate.
• Investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Focuses on continuous improvement by championing value improvement projects (VIP).
• Lead audit back room and provide front room support for External audits and ensure that the Production unit is audit ready at all times.
• Coordinate and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using eCAPA and BSC Engineering Essentials.

Education & Experience

• Honours Bachelor’s degree in Engineering, Science, or related field.
• Minimum 5 years of related work experience in a Quality Engineering role within medical device manufacturing including minimum 2 years’ experience as a people leader.
• Proven experience leading cross-functional teams and managing complex quality issues.
• Strong analytical, communication, and project management skills
• Ability to work independently; organized and self-driven.
• A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.
• Demonstrated understanding of QSR and ISO standard requirements for medical devices.

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Key Roles & Responsibilities:

• Learns to 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.
• Gains 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.
• Learns Process 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.
• Responsible for the final Process Monitor Release for products prior to distribution.

Education & Experience:

• Minimum of Hons Bachelor of Science Degree in Engineering/Technology.
• 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience in the medical device industry is an advantage.
• Experience on an automated/high volume line an advantage.

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Job Purpose:

To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

Key Responsibilities:

• Be the Subject Matter Experts with regard to Acceptable Quality Standards for products and processes.
• Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Represent QA as the first point of contact for daily line support issues.
• Troubleshoot product and process related issues and identifies root cause.
• Be an agile team member who can support all functions required based on shift requirements.
• Complete investigation of customer complaints.
• Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these.
• Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
• MRB: Provide disposition for any non-conforming product and identify appropriate corrective action with other support team members.
• Participate in internal quality audits.
• Trending and analysis of key Quality metrics.

Education & Experience:

• NFQ Level 6 or above in Science or Engineering Discipline.
• 2-5 Years experience in a similar position or medical device background.
• Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
• Learning ability, to learn an automated process and be comfortable to support on shift as required.
• Good interpersonal, planning & prioritising and communication skills are required for this role.

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