Quality Engineer

The Quality Engineer reports to the Quality Operations Manager

What You Will Do:

• Possesses and applies a broad and increasing knowledge of Quality, and its application within IDEM Business Unit, to the completion of moderately complex assignments.
• Broad knowledge of the organization’s operations and practices to enable informed decisions in day-to-day operations and assignments.
• Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. 
• Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration. 

What You Will Need:

• Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions
• Third level qualification
• Proficient with Excel, Power Point and ability to navigate web based applications.
• competent working knowledge of recognized Quality Management Standards (e.g. ISO9001/ ISO13485/ ISO14971/ GMP)
• Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
• Broad knowledge of engineering and technical applications applied in development of medical devices useful

What You will Receive:

• Competitive salary, career progression & training & development opportunities

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

There's never been a better time to be a part of Boston Scientific. This is an exciting moment: when our legacy of industry leadership intersects with the promise of a brilliant future. Today, we're 23,000 colleagues strong, with an impressive portfolio of 13,000 products. We’re at the forefront of the medical device industry – leading, evolving and transforming it into bolder and more amazing territories.

We are currently recruiting for an experienced Quality Engineer to join our Galway site on a fixed term basis with view to permanency.

Purpose

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their 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. Ensures their 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.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Continually seeks to drive improvements in product and process quality.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Knowledgeable on Risk Management , BSEN 14971 requirements.
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
• Is familiar with the internal auditing process

Qualifications and Experience:

• NFQ Level 8 (240 Credits) qualification in a STEM discipline
• Minimum of 3-4 years experience in a Quality Engineering capacity.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
• Proven ability to work well as part of a team & on own with minimum supervision.

   

Sterilisation Validation Engineer I | 18Month Contract | Galway.

Our client, one of Galway’s leading Medical Device company are looking for a Sterilisation Validation Engineer to join their team on an 18-month contract.

You will be working within the Sterilisation Validation Department where you will be focusing on product quality and work alongside Sterility Assurance for New Product Development. 

Initially for this role you will be remote. 

You will be responsible for:

• Supporting Sterility Assurance activities for new products and change controls at both design and manufacturing sites.
• Partake in root cause investigations and continuous improvement in your daily activity and initiate appropriate corrective actions and follow through to implementation.
• Support EU MDR project work for Sterilisation Validation team.
• Help support cross functional teams in design protocols to make sure that new products/ product changes are evaluated/ tested to guarantee compliance to all regulatory standards.
• Support projects in internal and external audits and with submission preparation while also addressing any questions around these submissions.
• Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
• Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes.
• Adhere to all relevant site wide procedures and practices for Safety & GMP.

Your experience:

• Degree (Level 8) qualification in relevant technical discipline such as Science or Engineering.
• 2 years’ experience with Sterilisation Validation or Biocompatibility is preferred.
• Excellent understanding of GMP and documentation required.
• Can work effectively and proactively as an individual or on cross functional teams

If you are interested in this role please apply with an updated CV to Rebecca O'Connor at

ROconnor@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Design Assurance Engineer

The Design Assurance Engineer ensures that R&D projects are executed in accordance with industry standards and that appropriate product verification and validation activities are implemented to support marketing applications for the device(s).

Responsibilities:

• Work within the Quality System ensuring that the quality policy and company systems and procedures are complied with, in line with FDA Quality Systems Regulations, ISO 13485, ISO14971 and all relevant standards
• Support R&D in the preparation and delivery of Design Reviews and associated checklists
• Establish and maintain the Design History File and associated documents
• Provides design quality support in the resolution of complaints investigation, CAPAs, regulatory requirement changes
• Conduct education and training with team members to ensure that best-in-class levels of compliance are maintained
• Keep up to date on best practices and constantly seek to improve compliance and efficiencies in line with best practices

Experience:

• Degree in Engineering/Science or related discipline
• Minimum 3 years’ experience in a relevant role in the medical device industry
• Experienced with ISO14971 Risk Management Systems
• Advanced knowledge and experience with medical device regulated design control systems including advanced knowledge of design verification and validation methods
• Highly developed written and verbal communication skills
• Proven ability of working in a cross-functional team environment
• Knowledge and practical experience with the use of statistical techniques in design verification and validation
• Training and experience in auditing (internal auditing, supplier auditing or similar)
• Strong communication and presentation skills are desirable
• Thinks Critically and Makes Sound Decisions
• Collaborates and Creates Alignment as a Team member

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

This job offers defined career advancement opportunities in a multi-cultural,rich environment. In this role, you will provide Complaint Handling, Vigilance Reporting and Post Market Surveillance support to business units across a number of geographical regions. 

What You Will Do:

• Escalation point for on-conformances and CAPAs
• Provide technical direction to Quality and Regulatory teams
• Foster a culture of compliance towards Quality & regulatory requirements across all business units
• Lead & promote continuous improvement initiatives & Quality Projects

What You Will Need: 

• Bachelor Degree (Level 8 in Science, engineering or nursing preferable)
• 8 years of work experience in medical device industry with minimum 3 years in Senior roles
• Knowledge of Quality Management Systems & Regulations - ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP

What You Will Receive:

• Excellent remuneration package
• Unparallelled opportunties for career growth & development opportunities
• A rich, diverse work environment

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

ByrneLooby is an international consulting engineering practice. We work with our clients to deliver value solutions for challenging projects across Europe, North Africa and the Middle East. We realise that our clients need much more than engineering designs - they need functional solutions that deliver value. We are passionate about engineering and always strive to optimise solutions for clients.

We have worked with contractors and construction professionals for many years and we understand the importance of delivering solutions that are buildable, simplify construction and consider all construction stages. Our solutions consider construction costs, construction sequence and programme. Our team of engineers is aware of the importance of being reliable and responsive when working with the construction team to deliver a project.

Our team has a wealth of experience and they provide reliable advice. Our team has the ability to diagnose complex situations and provide remediation or alternative solutions. We also have many years’ experience carrying out complex numerical analyses and doing back analysis and investigation work. Our team can provide expert advice and support on challenging projects from inception to completion and decommissioning.

• The candidate will have responsibility for client interface, technical direction, budgetary control and day to day management of junior engineers
• Management of relationships with key clients and contacts across the business including client liaison and development
• Management of projects within time, cost and quality constraints and standards
• Management of the day-to-day work
• Monitors and manages compliance and KPI’s
• Preparation of tender submissions
• Estimating, pricing and delivering against work targets
• Management of projects in compliance with ByrneLooby’s Integrated Management System (IMS)
• Ensure project staff are aware of, and fully compliant with, the requirements of the IMS

Experience Criteria

• 5+ years’ experience in Geotechnical design
• Has achieved Chartered status
• Ideally, have a degree in Civil Engineering and Masters in a Geotechnical related field

Skills & Knowledge

• Deep understanding of the principles of Geotechnical Engineering and earthworks
• Demonstrate an ability to understand complex problems and to conceive innovative solutions
• Experienced & confident with report writing and presentation skills
• Can effectively communicate with clients, colleagues and outside agencies and build effective working relationships and always aiming to exceeding client expectations
• Adheres to all Codes of Practice, Design Standards and Health and Safety Regulations
• Represent and promote ByrneLooby in a professional manner and develop effective working relationships with clients and potential clients
• Is committed to Continued Professional Development
• Experience of geotechnical software – FREW, WALLAP, PLAXIS, SlopeW, Holebase, SEEPW, etc.

ByrneLooby is an equal opportunity employer

As a Firmware QA Test Engineer you will estimate, plan, and coordinate testing activities. You will also ensure that quality issues and defects are appropriately identified, documented, tracked and resolved.

• Degree in science or engineering, or related disciplines
• 3-5 years’ experience with telematics based software testing or firmware testing
• ISTQB Foundation Level certification
• Proven experience with automation testing, ideally using keyword-driven testing tools such as Robot Framework
• Familiarity with scripting languages such as Python
• Demonstrated knowledge of system development life cycle methodologies
• Demonstrated knowledge of QA processes, tools and methodologies
• Proven diagnostic and debugging skills

• Become familiar with both hardware and software being tested

• Work with development team to clearly understand requirements and test data needs

• Review and signoff on requirement documentation

• Review risk registers and include relevant QA project risks

• Develop test cases and perform manual testing in Waterfall environment

• Design and run automated test cases

• Assist with building up a regression test suite

• Create comprehensive bug reports

• Record test results and verify bug fixes

• Reporting of test coverage and progress

• Preparation of test strategy and test report documentation in compliance with the appropriate  regulatory requirements

• Ensure all QA documentation is to a high standard to pass company audits

• Self-starter/Ability to work on own initiative

• Work in line with agreed company processes