Full-Time

Sr. Manager Design Quality Assurance

Posted on 6/11/2024

Sibel Health

Sibel Health

51-200 employees

Advanced sensor technology for healthcare analytics

AI & Machine Learning
Data & Analytics

Compensation Overview

$140k - $170kAnnually

+ Professional development stipend + Employer matching Simple IRA plan + Company-sponsored events

Senior

Chicago, IL, USA

Requirements
  • Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
  • Minimum of 8-10 years of experience in design quality assurance within the medical device industry.
  • Proven track record of leading quality assurance teams and managing design quality processes for medical devices.
  • In-depth knowledge of regulatory requirements and standards (e.g., 21 CFR 820.30, ISO 13485, ISO 14971, ISO 62304, ISO 62366, etc.)
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent communication, leadership, and interpersonal skills.
  • Ability to thrive in a fast-paced, dynamic startup environment.
Responsibilities
  • Develop and implement a comprehensive design quality assurance strategy aligned with Sibel Health's mission and goals.
  • Lead, mentor, and manage a team of quality assurance professionals, fostering a culture of continuous improvement and excellence.
  • Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, product management, and clinical teams to ensure seamless integration of quality assurance processes.
  • Oversee all aspects of design quality assurance activities, including design verification and validation, risk management, and compliance with applicable regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820).
  • Ensure compliance with global regulatory requirements and standards established by agencies, including but not limited to the FDA, EU Commission, TGA, Health Canada, and other relevant regulatory bodies.
  • Drive continuous improvement initiatives in design quality processes, methodologies, and tools to enhance product quality and development efficiency.

Sibel Health is a pioneer in the healthcare technology sector, specializing in the development of soft, flexible sensors integrated with cloud technology, optimized for artificial intelligence and machine learning. This focus not only leads to enhanced healthcare solutions but also fosters a culture of technical excellence and continuous innovation. The company's commitment to delivering Better Health Data for All through its cutting-edge products positions it as a leader in its field, providing a dynamic and forward-thinking work environment.

Company Stage

Series B

Total Funding

$85.7M

Headquarters

Chicago, Illinois

Founded

2018

Growth & Insights
Headcount

6 month growth

19%

1 year growth

78%

2 year growth

170%