Design Quality Engineer

at  Natus Medical Incorporated

IF YOU ARE LOOKING FOR A CHALLENGING OPPORTUNITY TO WORK IN AN INTERNATIONAL ENVIRONMENT, THEN WE MAY HAVE A JOB FOR YOU. WE ARE LOOKING FOR A SELF-STARTER AND ENTHUSIASTIC DESIGN QUALITY ENGINEER TO JOIN OUR GLOBAL QUALITY ASSURANCE TEAM FOR A 12 MONTH CONTRACT.

Location: This role can be offered on a remote or hybrid basis to suit the successful candidate.

EDUCATION AND/OR EXPERIENCE:

• Requirement: Level 8 Degree in Engineering preferably Electrical/Manufacturing
• 4-6 years of experience in Quality Assurance or Design Assurance in the medical device industry, including experience with design controls and design transfer activities
• Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
• Strong CAPA experience
• Demonstrated excellent organizational skills and ability to work on own initiative essential.
• Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken

• Provides support to product development and sustaining teams including but not limited to design input/output, verification/validation, risk management, and design transfer activities
• Drives streamlining improvement initiatives in the Quality Management system across the site
• Ensures quality system compliance to ISO13485, 21CFR 820, MDSAP and Medical Device Regulations
• Prepares metrics in support of trending and management reviews
• Provides quality inputs in product design updates and support design maintenance releases
• Conducts internal audits when needed and serves as Quality System support for Regulatory and Corporate Audits
• Takes ownership of managing and closing out CAPAs where required.
• Guides product transfer activities and streamlining of quality management systems
• Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers