Sr Quality Engineer, Capital Equipment

Imperative Care • Campbell, CA

18h • $120,000 - $150,000 • Onsite

About The Position

As a senior professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care’s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company’s Quality Policy and Quality Objectives.
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

Requirements

• 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 addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level