- Responsible for ensuring compliance with all federal, state, local, and company regulations, policies, and procedures.
- Responsible for defining supplier qualification requirements and drive deliverables to obtain supplier approval.
- Works with suppliers to ensure quality system requirements are understood and successfully met.
- Develop, update, and maintain inspection methods including validation activities.
- Review and approve technical documents.
- Lead special projects in collaboration with multi-functional team members.
- Develop and provide trainings to enable seamless knowledge transfer of projects.
- Support Nonconformance/CAPA/SCARS activities.
- Bachelor degree in engineering or science field with a minimum 4 years' experience in medical device manufacturing.
- Knowledge and understanding of FDA and international regulatory standards for medical devices.
- Strong documentation, communication and interpersonal relationship skills
- Thorough understanding of root cause analysis principles, FMEA process, GR&R and process capability. Understanding statistical techniques, test method development
- Collect, document, and analyze test data.
- Develop and perform test method development and validation for equipment and product designs; experience with development of validation protocols
- Ability to work independently without close supervision.
- Previous medical device or pharmaceutical industry experience is preferred; Experience with Class III medical devices or experience with implantable devices a plus
- Ability to read and interpret drawings.
- Strict attention to detail.
Sthree US is acting as an Employment Business in relation to this vacancy.