Job Overview
The Quality Team Lead helps support Design Transfer and Product Care activities through new product development and process development through the application of Quality engineering skills for medical device products.
Main Responsibilities
- Oversee local Quality Engineering, Manufacturing Quality Assurance and Quality Control teams
- Ensures that all related design control and production and process control projects meet applicable regulatory requirements
- Handles material disposition in relation to process deviations
- Promotes the use of statistics in the verification & validation, testing and control of quality
- Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System
Required Skills & Qualifications
- Technical or Scientific degree at the University level (mechanical, industrial, biomedical, chemical engineering, material/life science)
- Demonstrated experience in a management position
- At least five year's work experience in a Product Development/Design Assurance function in regulated environment
- Experience in the design and development of products in accordance with ISO 13485 guidelines and ISO14971
- In depth know-how and experience of quality and lean techniques: Six Sigma methods such as DMAIC, DoE, FMEA, MSA, etc., ideally holds a Black Belt certification
