Sr Quality Engineer, Capital Equipment

• Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process (e.g. requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control).
• Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulations.
• Collaborates with team members to define requirements, specifications, testing, and component/product acceptance activities.
• Participate in risk management process ensuring that all the risks were properly identified/assessed and update risk management files accordingly.
• Direct interaction with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities.  May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance

• Bachelor’s degree in related field (science, industrial operations, mechanical, biomedical, or electrical engineering) and a minimum of 5 years’ work experience in the medical device, or related regulated industry experience; or equivalent combination of education and work experience
• Experience working with electro-mechanical medical device, robotics, or medical software is highly desired.
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations
• Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.