Staff Quality Engineer - Cork, Carrigtwohill IDA Business & Technology Park Tullagreen

Work Flexibility: Remote or Hybrid or Onsite

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

Travel Percentage: 10%