Medical Technology Solutions Leader

4 hours ago

Limerick, Limerick, Ireland beBeequality Full time €90,000 - €110,000

Job Overview:

  • We are seeking a Quality Engineer 3 to lead all phases of product realization including NPD, NPI, Commercialization, Sustaining, and End of Life.

 

Responsibilities

As a Quality Engineer 3, you will be responsible for bringing creative, innovative, and sound quality decision-making to the team. You will ensure effective implementation of the required QMS documentation and professional communication with all stakeholders. Key responsibilities include:

  • Quality oversight on problems of diverse scope, demonstrating good judgment in selecting methods and techniques for obtaining solutions, driving corrective actions, and verifying effectiveness for assigned area.
  • Oversight of QA inspection, testing, and release.
  • Guiding, supporting, and training other quality team members.

 

Key Performance Indicators (KPIs)

The following KPIs will be used to measure your success in this role:

  • Compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
  • Troubleshooting quality issues identified during product development and commercialization and driving solutions to reduce non-conformances.
  • Quality input and guidance on Validation planning and documentation utilizing risk-based decision making and driving risk mitigation activities into process development and product quality assurance.
  • Vendor and part appraisal and approval processes.
  • Process change and related assessment and implementation of change notification.
  • Statistical techniques and visual control systems to monitor manufacturing processes.

 

Requirements

To be successful in this role, you will need:

  • A seasoned, experienced professional with a full working knowledge of EN ISO 13485, the principles of GMP, and FDA QSR 21 CFR Part 820.
  • Degree in an engineering/quality or related discipline.
  • Certified QE desirable.
  • Technical report writing.
  • Process validations/FMEA's and protocols.
  • Proficient in Statistical analysis.
  • Structured Problem-Solving techniques – Lean Six Sigma Green Belt desirable.
  • Understanding of Lean Principles.
  • Ability to drive projects to completion.
  • Guided by the disciplines of due diligence and compliance in all aspects of work.

 

Benefits

This role offers:

  • A dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
  • The opportunity to work in a fluid, demanding environment.
  • The ability to gain technical understanding of Teleflex processes and products.
  • The ability to understand customer/vendor relationships.
  • The ability to generate appropriate relationships with customers and vendors.
  • The ability to deal with difficult customer or vendor communications.
  • The ability to influence customers/vendors where necessary.
  • The ability to understand the key drivers of our manufacturing business.

 

TRAVEL REQUIRED: up to 10%

],

  • Manager Product Development R&D

    1 day ago

    Limerick, Limerick, Ireland Bd Medical Full time

    Job Description Summary Join BD's mission to advance the world of health as a Technical Leader in Pharmacy Automation.In this role, you will lead the design and development of complex medical device portfolios, driving innovation from concept to launch.You'll collaborate cross-functionally to define product strategy, mentor engineering talent, and implement...

  • Director R&d

    3 weeks ago

    Limerick, Limerick, Ireland BD Medical Full time

    Job Description Summary BD Biosciences is a world leader in providing innovative flow cytometry diagnostic and research tools to laboratory professionals, clinicians, and clinical/life science researchers.The Director will serve as a key technical leader for new, flow cytometry based, clinical assay projects, making informed recommendations on all...

  • Senior Systems Engineer

    3 weeks ago

    Limerick, Limerick, Ireland BD Medical Full time

    Job Description Summary BD's Medication Management Solutions (MMS) division seeks a Senior Systems Engineer for the growing Pharmacy Automation team, developing innovative technology for pharmacies. The Senior Systems Engineer will drive the design and validation of complex systems, collaborating with cross-functional teams. Job Description We are the makers...

  • Validation Sales Solutions Engineer

    2 weeks ago

    Limerick, Limerick, Ireland Kneat Solutions Full time

    Validation Sales Solutions Engineer - North AmericaJoin to apply for theValidation Sales Solutions Engineer - North Americarole atKneat SolutionsValidation Sales Solutions Engineer - North America1 day ago Be among the first 25 applicantsJoin to apply for theValidation Sales Solutions Engineer - North Americarole atKneat SolutionsGet AI-powered advice on...

  • Validation Sales Solutions Engineer

    1 day ago

    Limerick, Limerick, Ireland Kneat Solutions Full time

    Validation Sales Solutions Engineer - North AmericaJoin to apply for theValidation Sales Solutions Engineer - North Americarole atKneat SolutionsValidation Sales Solutions Engineer - North America1 day ago Be among the first 25 applicantsJoin to apply for theValidation Sales Solutions Engineer - North Americarole atKneat SolutionsGet AI-powered advice on...

  • Validation Sales Solutions Engineer

    1 week ago

    Limerick, Limerick, Ireland Kneat Solutions Full time

    Job Description: Validation Sales Solutions Engineer - North AmericaKneat enables regulated organizations to move from paper-based validation to intelligent, digitized, paperless solutions.And we do it through the ongoing development of a powerful, purpose-built software platform.In 2014, after 8 years of intensive software development, we launched the...

  • Validation Sales Solutions Engineer

    1 day ago

    Limerick, Limerick, Ireland Kneat Solutions Full time

    Job Description: Validation Sales Solutions Engineer - North AmericaKneat enables regulated organizations to move from paper-based validation to intelligent, digitized, paperless solutions.And we do it through the ongoing development of a powerful, purpose-built software platform.In 2014, after 8 years of intensive software development, we launched the...

  • Innovative Medical Device Portfolio Development Leader

    40 minutes ago

    Limerick, Limerick, Ireland beBeeLeadership Full time

    Senior Technical LeaderWe are seeking a seasoned Senior Technical Leader to spearhead the development of complex medical device portfolios.This role offers an exceptional opportunity to lead cross-functional teams, drive innovation, and shape the future of healthcare technology.Lead technical development of multiple product portfolios, driving...

  • Validation Sales Solutions Engineer

    18 hours ago

    Limerick, Limerick, Ireland Kneat Solutions Full time

    Validation Sales Solutions Engineer - North AmericaJoin to apply for the Validation Sales Solutions Engineer - North America role at Kneat SolutionsValidation Sales Solutions Engineer - North America1 day ago Be among the first 25 applicantsJoin to apply for the Validation Sales Solutions Engineer - North America role at Kneat SolutionsGet AI-powered advice...

  • Staff R&d Engineer

    4 weeks ago

    Limerick, Limerick, Ireland BD Medical Full time

    Job Description Summary As the Staff R&D Engineer, you will contribute to cross-disciplinary product development teams and may lead the definition, design, and execution of Systems Engineering activities throughout all phases of the product lifecycle.Job Description We are the makers of possible BD is one of the largest global medical technology companies in...