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New Product Introduction Quality and Validation Engineer (m/f/d)

Req ID: J2374725-IL

  • Location
    Waterford, Waterford, Ireland
  • Category Quality Group
  • Posted Monday, November 20, 2023
  • Type Full time
  • Job Type Permanent Employee

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 250,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

Job Description

For our site in Waterford, Ireland we are looking for

New Product Introduction Quality and Validation Engineer (m/f/d)

The Quality and Validation Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.  Ensures that performance and product quality conform to established company, customer and regulatory requirements, supports New Product Introduction activities relating to Quality for products, processes or technologies, and for the enhancement or extension of existing product lines.

Key Responsibilities and End Results

  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical Device/Medicinal Product perspective all FDA, QSR, MDR & EU GMP standards/guidelines are achieved and maintained in respect to device classifications.

  • Participation in the writing of User Requirement Specifications for new or changed Facilities (Cleanrooms), Automated Assembly Lines and Manufacturing Equipment.

  • Generating of Equipment Qualification Protocols and Reports and support the Engineering Team with its execution.

  • Cleanroom and Utilities validation protocols and reports (Execution and Review)

  • Generating Validation strategies, plans and protocols for NPI manufacturing processes in compliance and alignment to the Client specification and expectations, ensuring the process & product are operational ready post Validation.

  • Support the transfer of ownership from NPI to Production phase, liaising with Programs Group and Operations Work Cells.

  • Conduct and Report Risk Management activities including conduction of End to End Process FMEA’s,

  • Generating Risk Management Plans and Risk Assessment Reports.

  • Support investigations and root cause analysis for issues identified during the NPI/Validation phase of projects.

  • Generating NPI Quality and Validation Deviations and CAPA required during the NPI and Validation stages of a project.

  • Metrology/Data Processing (Statistics), Process Capability calculations and correspondent reporting

Client Facing activities:

  • Aligning customer specifications to JABIL capabilities.

  • Presentation of Quality and Validation Plans/Strategies to Clients during face to face/remote Project meetings.

  • Address Client Quality, Validation and Technical queries during the lifecycle of NPI projects during project meetings,

  • Provide Clients with Quality and Validation Rationales that support both internal, Client and Regulatory requirements.

  • Represent NPI Quality and Validation in Clients Audits and/or Technical Visits and Regulatory Inspections.

  • Support the generation of DMF’s and other applicable regulatory documents where appropriate.

  • Ensure projects are prioritized in line with business needs.

  • Support NPI Quality and Validation Lead with on-going projects and new business developments and/or opportunities.

  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.

  • Support the external & internally Quality Management System auditing function.

Minimum requirements:

  • Bachelor's degree required

  • 2 years related experience; or equivalent combination of education and experience in Medical Device and/or Pharma Industry.

  • Preferably with Knowledge/experience of manufacturing engineering, exposure to high volume medical device or pharma automated assembly lines.


  • Excellent organization, communication, computer & presentation skills.

  • Excellent initiative, decision making and be able to work in a core team environment.

  • Excellent time management skills.

  • Solution driven with emphasis on performance and results.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.

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