Staff Quality Engineer

Stryker • Full-time • Cork, Ireland • 3w ago

Work Flexibility: Hybrid or Onsite

*Please note this is a 23 month Fixed Term Contract

- Onsite role

Position Summary

Provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

What you will do:

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 possessstrong 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

Highly developed problem-solving skills,

Strong analytical skills

Demonstrated ability to successfully manage and complete projects in a matrix organisation

Demonstrated ability to work independently and as part of cross functional teams

Experience in working in a compliance risk situation

Previous industry experience required

Computer literacy

Some travel may be required

What you will need:

- Level 8 Degree- STEM subject

- 4 years experience required

Travel Percentage: 10%

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