DeepSight Technology Inc. is a stealth-mode startup company that has developed breakthrough technology in ultrasound imaging. This new technology will both extend the range and clarity over current systems by 10x - 100x! We are setting new standards that will dramatically improve the capabilities of ultrasound for many years.

In order to develop and improve this technology, we need dedicated team players. Not only do we offer a great team-oriented environment, but we also offer competitive compensation and generous benefits. This position is located in St. Louis, MO or Santa Clara, CA.

Job Description

The Manager of Quality Assurance plays a pivotal role in ensuring the quality, safety, and compliance of DeepSight's medical devices. As a founding member of the Quality team, the role will lead the Company's Quality efforts by developing, implementing, and maintaining an electronic quality management system for the design, development, and manufacturing of medical devices and disposables. This includes working with R&D on new product development through all project phases, providing input on process quality requirements. The role also oversees the data, policies, procedures, and systems to ensure compliance with US Medical Device regulations and other worldwide regulations that will result in a culture of excellence in quality and Deepsight's ultimate commercial success.

Responsibilities include:

• Develop, implement, and maintain an electronic Quality Management System (QMS)
• Develop and execute a quality strategy that leads to a high-performing and compliant Quality System, including on-time Regulatory submission strategies and approvals.
• Develop a compliant new product development process with adherence to FDA Design Control requirements which ensures quality plans, specifications, training, and full validations are complete and ensures a smooth transfer to production
• Plan, lead, and execute all internal and external audits of the Quality Management System and ensure they are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement
• Work with cross-functional teams in preparation of regulatory filings
• Organize, review and prepare the Management Reviews.
• Represent the Quality Department during Senior Management meetings in order to report status and recommend areas for improvement
• Represent Quality in Audits, Complaint Handling and CAPA. Oversee the complaint handling and corrective and preventive action (CAPA) processes to ensure timely resolution of issues and prevention of recurrence
• Responsible for Supplier Quality Management. Collaborate with suppliers to ensure the quality of raw materials and components used in our products.
• Conduct supplier audits and assessments as needed.
• Stay up to date with regulatory requirements to support our product and processes compliance to the following standards: 21 CFR 820, ISO 13485, and IEC 62304

Qualifications

Required skills/qualities/experiences:

• BS in Biomedical, Mechanical or Electrical Engineering or other Technical Science
• 7 years' experience in quality system development and management with extensive experience in medical device quality assurance
• Experience with Class II or Class III medical devices
• Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR
• Lead Auditor or trained as an internal auditor
• Strong ability and desire to engage, coach, and teach cross-functional team members regarding Quality System and medical device requirements
• Position is located in greater St. Louis, MO or Santa Clara, CA, must be willing to relocate

Preferred skills/qualifications:

• 10 years' experience in quality system development and management with extensive experience in medical device quality assurance
• Significant experience and personal interactions with FDA and other regulatory agencies through audits and product submissions
• Experience in early-stage startup
• Experience in all 5 phases of the product development lifecycle
• Knowledge of project management best practices
• Experience with Design Controls, Product Development, and day-to-day management of QMS
• Detail oriented, well organized and have excellent communication skills
• Able to manage internal quality team and work well with cross-functional team and all levels of the organization
• Able to accomplish objectives with minimal supervision

Other Qualities We Are Looking For:

• Positive - a can-do attitude that helps you rise to challenges
• Collaborative - a team player who can effectively communicate with others
• Attentive to detail - nothing gets by you • Efficient - a knack for effectively prioritizing tasks and managing your time
• Pride in your work - real desire to do quality work
• Career-minded - looking for more than a job

Benefits and Perks

• We offer great benefits and perks:
• Competitive salary
• Stock options
• Medical, dental, and vision insurance
• 401(k) retirement plan