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Senior Quality Assurance Manager
2 months ago
Quality Assurance Manager Role
We are pleased to present an exciting opportunity for a Quality Assurance Manager at a prominent small-scale medical device organization in San Diego. This pivotal role is crucial for the ongoing development and prosperity of the company. The successful candidate will be responsible for leading a dedicated team while maintaining a hands-on approach, promoting a culture centered around quality excellence. The organization boasts a collaborative and vibrant culture, making it an ideal workplace.
Role Overview:
- Act as the Management Representative, ensuring adherence to Quality Management System (QMS) standards.
- Guide and nurture the Quality Team.
- Supervise all QMS-related activities.
- Manage Quality Goals and conduct audits.
- Initiate quality improvement actions based on data evaluation.
- Lead both internal and external audit processes, including supplier audits.
Qualifications and Experience:
- Bachelor's degree in a life sciences discipline or a related area.
- A minimum of 7 years of quality management experience within the medical device sector.
- At least 3 years in a managerial capacity.
- Proven expertise in QMS governance and applicable standards.
Essential QMS Standards and Regulations:
- In-depth knowledge of relevant regulations, including ISO 13485 and others.
Work Environment and Physical Requirements:
- Regular communication and occasional lifting may be necessary.
- Primarily work in a standard office setting.
- Moderate noise levels are expected in the work environment.
Compensation Package:
Salary range of $115-140K, plus performance-based bonuses - title and compensation will be determined based on experience.
