1) Provide technical support and project management for all departments of the Company.
2) Ensure adherence to quality and safety standards of all components manufactured for the Company.
3) Responsible for creation and implementation of product development quality documents.
4) Works with external engineering resources to achieve new product development objectives.
5) Performs design activities in compliance with design control processes and procedures.
6) Perform product development activities.
7) Identifies and oversees implementation of development, manufacturing, inspection, packaging and sterilization changes.
8) Performs all development activity in compliance with established design control procedures and standards.
9) Ensures that development prototypes are manufactured in compliance with all standards required to meet FDA and CE Mark requirements.
10) Initiates, maintains and updates all quality records related to product development, nonconforming products and related corrective actions.
11) Ensures quality records conform to FDA and ISO guidelines.
12) Reviews and provides input on the company's key medical, technical, clinical and regulatory reports and filings.
13) Works with external consulting firms providing product development support.
1) University Degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (No students or fresh graduates please)
3) Recent experience in the Medical Device industry is strongly preferred
4) Preference will be given to people have recent experience in Manufacturing