Director Quality Assurance

Imperative Care • Campbell, CA

1d • $234,000 - $244,000 • Onsite

About The Position

At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only are we changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.

As head of a quality sub-function, the Director of Quality Assurance will interpret functional strategy to set goals and objectives for assigned team to ensure the quality of our products and operations. This position will be leading the activities of building our quality policies for robotics product to be compliant with applicable medical device regulations. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants. An individual in this role will create and maintain the Quality Management System (QMS) and building the quality assurance team to promote quality principles across engineering, manufacturing, and elsewhere.

Requirements

• Bachelor’s degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience.
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971; IEC 60601-1 and related regulations.
• New product development experience required.
• Excellent leadership and management skills.
• Excellent verbal and written communication and presentation skills.
• Effective interpersonal skills with proactive leadership skills to determine deficiencies, communicate them effectively through the organization and follow through to resolution.
• Ability to work effectively with employees at all levels of the organization.
• Willingness to perform a “hands-on” troubleshooting and problem-solving activities.
• Good technical understanding of Design and Process Validation principles.
• Ability to comprehend principles of engineering, physiology, and medical device use.

Nice To Haves

• Preferred ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).

Responsibilities

• Serve as the quality management representative for the robotics business.
• Provide strategic leadership of the quality system to ensure continued conformance to applicable domestic and international regulatory standards.
• Ensure compliance with quality and regulatory requirements: 21 CFR part 820, ISO 13485, MDR 2017/745.
• Coordinate and lead the definition of the quality and regulatory strategy, in collaboration with upper management and regulatory consultants.
• Define, build, implement, and maintain the company QMS to support product development and company growth from concept through commercial launch; provide and conduct training for stakeholders as appropriate.
• Provide support on quality and regulatory matters to critical suppliers.
• Ensure the quality of our product development and verification/validation activities, including the compliance to applicable regulatory standards.
• Grow and oversee the activities performed by a Quality team.

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: Director