- Deliver on all KPIs that help the business achieve its goal. They may have primary responsibility for specific KPI's for the business area.
- Lead and drive QA initiatives within area of functional responsibility.
- Provide technical support to the Quality Technicians
- Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
- Lead, coordinate & maintain risk assessment documentation e.g. FMEA's, for their assigned product(s)
- Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
- Strategically lead new product introduction and contract reviews from a QA perspective where assigned
- Lead assigned projects from a quality perspective including process improvements, SCN's, Notification of Changes, Contract Reviews and alternative materials.
- Prepare and updating Operations procedures and associated documentation.
- Responsibility for assigned functional area GMP standards and compliance including the promotion of Quality awareness.
- Establish inspection standards, sampling plans, and test methods.
- Report Quality metrics.
- Develop strong links with customer organisations and other project stakeholders.
- Quality review of functional area validation documentation.
- May have responsibility to manage the day to day activities of inspector or student level resources in a safe environment and be responsible for Health and Safety goals.
- Perform and support internal and external audits to ISO and FDA requirements.
- Perform an active role in further development and continuous improvement of the Quality Management system.
- Other tasks as directed by the Operations Quality Manager or Quality Supervisor in line with company goals and objectives.
- Level 8 degree in Science / Engineering or related fields.
- Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
- Experience in CAPA.
- Experience in root cause analytical and problem-solving skills.
- Knowledge of FDA and ISO Quality systems for Medical device companies desirable.
- New product introduction and manufacturing process transfer experience desirable.
- Test method and process validation experience
- Demonstrated excellent organizational skills and ability to work on own initiative essential.
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Quality Engineer
1 week ago
Celestica Galway, Ireland08 - Specialist, Operations Quality · Req ID: · Remote Position: No · Hiring Manager: Bobby Smith · Band: 08 · Region: Europe · Country: Ireland · State/Province: Galway · City: Galway · General Overview · Position Details: · Functional Area: Quality · Career Framework Titl ...
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Quality Engineer
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Cpl County Galway, IrelandQuality Engineer · My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer. · Supporting the Post Market QA team, supports the Business Units fulfil the ...
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Quality Engineer
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Quality Engineer I
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Boston Scientific Galway, IrelandOur Mission: · At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. · We work collaboratively to solve healthcare's toughest problems by developing solutions that matter most ...
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Senior Quality Engineer
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Senior Quality Engineer
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Abbott Galway, IrelandAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Software Quality Engineer
6 days ago
Abbott Laboratories Galway, IrelandSoftware Quality Engineer page is loaded · Software Quality Engineer · Apply locations Ireland - Kilkenny time type Full time posted on Posted 25 Days Ago job requisition id JOB DESCRIPTION: · Have you ever wanted to make a difference? · At Abbott, you will play a crucial rol ...
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VP Quality Engineering
3 days ago
Cpl County Galway, Ireland Full timeQUALITY ENGINEERING VICE PRESIDENT · We are seeking a multifaceted, forward thinking organizational leader who is passionate about the customer and committed to quality. Strategic mentality coupled with technical competence of Quality practices drives our ideal candidate toward ...
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Director - Quality Engineering
1 week ago
Cpl County Galway, Ireland Full timeDirector - Quality Engineering Chapter Lead · The Workplace Investing Quality Engineering team is seeking a multifaceted, forward thinking organizational leader who is passionate about the customer and committed to quality. Strategic mentality coupled with technical competence o ...
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Quality Engineer II
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Boston Scientific Galway, IrelandOur Mission: · At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. · We work collaboratively to solve healthcare's toughest problems by developing solutions that matter most ...
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Senior Quality Engineer
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Abbott Laboratories Galway, Ireland OTHERAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Quality Engineer Part Time
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Principal Supplier Quality Engineer
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Senior Software Quality Engineer
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Principal Supplier Quality Engineer
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Sterilisation Validation Quality Engineer I
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R&D Manager
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Electrical Equipment Design Engineer- Hybrid
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Sterilisation Validation Engineer I
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Collins McNicholas Galway, IrelandOur client a major multinational is seeking a Sterilisation Validation Engineer I on an initial 12month contract. This is a hybrid role. Responsibilities Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose A ...
sr quality engineer - Galway, Ireland - TE Connectivity
Description
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Job Overview
TE Connectivity's Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.Job Responsibilities
Other Responsibilities
Qaulificattion
Minimum of 5 years Quality Engineering experience with 4 Years industry experience in a medical device manufacturing environment
Key Requirements
Excellent written and verbal communication skills essential
Competencies
Values: Integrity, Accountability, Teamwork, Innovation WHAT TE CONNECTIVITY OFFERS:
We are pleased to offer you an exciting total package that can also be flexibly adapted to changing life situations - the well-being of our employees is our top priority
• Competitive Salary Package
• Performance-Based Bonus Plans
• Health and Wellness Incentives
• Employee Stock Purchase Program
• Community Outreach Programs / Charity Events
• Employee Resource Group
Across our global sites and business units, we put together packages of benefits that are either supported by TE itself or provided by external service providers. In principle, the benefits offered can vary from site to site.
