Staff Quality Engineer

4 weeks ago

Ireland Stryker Group Full time

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly talented and intelligentpeople, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team:

Who we are looking for:

  • Detail-oriented process improvers . Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
  • Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
  • Understanding of US and International Medical Device Regulations
  • Familiarity with ISO 13485, GDP, GMP required
  • Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously
  • Ability to represent Quality function within and across the project teams
  • Strong interpersonal skills, written, oral communication and negotiation skills
  • Strong in critical thinking and outside the box thinking
  • Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as SICRs, Data other items as applicable to the process.

What you will do:

Work within the Inspection optimization Team, Engineering services, responsible for quality engineering activities as applicable, including but not limited to the following:

  • The execution of initiatives & projects to optimize inspection at suppliers while ensuring compliance to regulation and standards.
  • Working with Colleagues at other Stryker/ Supplier sites as required ensuring that changes are processed compliantly.
  • Point of contact for supplier certification.
  • Point of contact for supplier inspection optimization changes.
  • Enable successful completion of internal supplier inspection optimizations.
  • Be able to identify risks/gaps and provide solutions to correct.
  • Technical Quality Expert that sets quality strategy by utilizing a risk based approach around optimization.
  • Independent Reviewer as required.
  • Provides feedback to lessons learnt for each completed assignment.
  • Work closely with operations and the business functions process SICRs
  • Supporting supplier certification and inspection optimisation at suppliers globally.
  • What you will need:
  • BS in a science, engineering or related discipline (Level 8).
  • MS, CQE, or CRE preferred.
  • Six Sigma Green or Black belt preferred.
  • Minimum of 4 years’ experience preferred.

This is a 23 month contract working on a project

About Stryker Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. #J-18808-Ljbffr

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