Do you have a passion for biotechnology and cancer treatment? Are you experienced in quality assurance in the medical devices or pharmaceutical industry?
Our client is a global biotechnology company developing precision, cell-targeting investigational therapies to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. This is a great opportunity for you to work on this cutting edge technology as a Sustaining & Quality Engineering Manager.
To be considered for this position, you must have the following qualifications:
* At least 3 years experience in the Medical Device industry.
* Experience with design control and risk management for Medical Device.
* Understanding of the product lifecycle of Medical Device including pre-market and post-market.
* Expertise in the mechanical design, polymer material and manufacturing engineering for medical devices are plus.
* Understanding of medical device regulations and guidelines, e.g. ISO13485, FDA 21 CFR Part 820.
* Bachelor's degree in engineering or related field
As the Sustaining & Quality Engineering Manager, you will be responsible for ensuring compliance to quality policies and regulations. You will also be required to communicate with external manufactures to improve and develop the medical devices. Therefore, strong communication skills along with strong understanding of quality regulations are critical success factors. Business level of English is essential for the role.
As part of your role, you will be responsible for the following:
* To lead the design control and risk management of the medical device.
* To be involved in cross-functional project(s) as engineering expert.
* To communicate with external manufactures to develop the medical devices.
* Build strong relationship with external partners.
* Compliance with Quality Policy and regulations
If you are interested in this opportunity, please apply with your CV attached.