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Senior Quality Assurance Manager

2 months ago


San Diego, California, United States Ignite Human Capital Full time

Quality Assurance Manager Role

We are pleased to present an exciting opportunity for a Quality Assurance Manager with a prominent small medical device organization in San Diego. This pivotal role is crucial for the ongoing development and success of the firm. The successful candidate will not only guide a dedicated team but also engage in hands-on activities, promoting a culture centered around quality excellence. The organization prides itself on its collaborative and vibrant work environment, making it an ideal workplace.

Role Overview:

  • Act as the Management Representative, ensuring adherence to Quality Management System (QMS) standards.
  • Provide mentorship and growth opportunities for the Quality Team.
  • Supervise all QMS-related activities.
  • Manage Quality Goals and conduct audits.
  • Initiate quality improvement actions driven by data insights.
  • Lead both internal and external audit processes, including supplier evaluations.

Qualifications and Experience:

  • Bachelor's degree in a life sciences discipline or a related area.
  • A minimum of 7 years of quality assurance experience within the medical device sector.
  • At least 3 years in a supervisory capacity.
  • Proven expertise in QMS governance and applicable standards.

Essential QMS Governance and Standards:

  • In-depth knowledge of relevant regulations, including ISO 13485 and others.

Work Environment and Physical Requirements:

  • Regular communication is essential, with occasional lifting required.
  • Primarily based in a standard office setting.
  • Moderate noise levels are expected in the workplace.

Compensation Package:

Salary range is between $115,000 and $140,000, plus a performance-based bonus - title and compensation will be determined based on experience.