Excellent Career Opportunity Quality Assurance & Compliance in NPD Team management

Singapore • Permanent

• Excellent Career Opportunity
• Quality Assurance & Compliance in NPD
• Team management

About Our Client:

Our Client is a fast-growing Medical Device company that manufactures medical devices to increase the quality of life of patients worldwide. They set up the R&D team 2 yers ago and it has been growing rapidly. Due to their rapid growth and commitment towards quality, product and innovation in the medical device industry, they are currently looking for a Design Quality Manager, NPD to be responsible for all Quality related actions supporting the New Product Development (NPD, Design Quality) and supporting systems.

Main Duties & Responsibilities:

Reporting to the VP of Quality, you drive new product development quality and ensure consistent and compliance product development process, support new product development and implementation of new products via development of an overall quality plan, including needed inspection, test, and audit procedures; identification of needed reliability testing; identification, procurement, and maintenance of needed engineering test equipment; and support of process/product validation. You would be administering inspection, test or any audit programs to ensure that all finished new products meet the functional specifications and quality standards. You are responsible for the passing of ISO13485 and other quality related certifications and audits. As a Quality Manager, you will also have to lead and drive the continuous improvement activities of the Quality process within your department. You champion and ensure design controls are in compliance and products are fully validated before entering the market. Also, you will have to work closely with the other departments and stakeholders, to ensure that they follow the right requirements and procedures in terms of Quality. You support Quality systems to ensure compliance to regulatory, accreditation and system requirements.You champion and maintain risk management activities.

Candidate Profile:

You must have a Bachelor’s Degree in Science related discipline with a minimum of 7-9 years of quality engineering experience in the medical device industry. You possess good working knowledge of FDA QSR, IVDD and ISO 13485 as well as understanding of Design Control Process. You are willing to travel.

What to Expect:

Our client offers a fulfilling career where growth is encouraged and the work environment is stimulating and challenging yet balanced. You will be working in a team-oriented function as well as an individual contributor and be part of an esteemed organization where new ideas are highly encouraged.

Please kindly send your CV to Erin Ong at or call +65 6593 8346 for a private discussion.

EA License No. 09C5803

Registration No. R1652768

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