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Quality Director

2 months ago

Boston, Massachusetts, United States Best Buy Health Full time
Job Title: Quality Director

Best Buy Health is seeking a highly skilled Quality Director to lead our Quality Assurance program for Software as a Medical Device (SaMD) and other medical devices. As a key member of our team, you will be responsible for ensuring compliance with relevant regulations, including ISO 13485, EU MDR, and FDA 820.

Key Responsibilities:
  • Lead the QA program to ensure compliance of SaMD and other medical devices
  • Develop and maintain a strong quality culture within the organization
  • Participate in strategic planning and decision-making for medical device development and commercialization efforts
  • Manage and conduct complex quality audits, inspections, and investigations
Requirements:
  • Minimum 5 years of experience in leadership roles within quality assurance (QA)
  • Prior experience working with a Quality Management System (QMS) for medical devices
  • In-depth knowledge of US, EU, and international regulatory requirements for medical devices
What We Offer:
  • Comprehensive benefits package, including tuition reimbursement and caregiver support
  • Generous Best Buy employee discount
  • Opportunity to work with a leading company in the healthcare technology industry

Best Buy Health is an Affirmative Action and Equal Opportunity Employer dedicated to creating an inclusive environment that values the diversity of our employees. We are committed to equal employment opportunity for all applicants and employees, without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other protected characteristic under applicable law.