Job Details
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
*Please note this is a 23 month Fixed Term Contract
- Onsite role
Position SummaryProvide 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
