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 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 

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%