- Drive a culture of Quality within the organization
- Implement and maintain SN&Ns QMS processes
- Review & improve quality system processes
- Work cross functionally to execute to the requirements under the QMS, drive opportunities for improvement and address potential gaps
- Responsible for implementing and managing supplier management program
- Implement and manage design quality assurance activities, including risk management
- Implement and manage product and process monitoring activities including management of non-conforming product, complaint handling, corrective and preventive action programs
- Implement and manage internal and external audits as required
- Implement and manage Document Control and Training Programs
- Drive and conduct annual management reviews
- Responsible for any additional quality activities as assigned by management
- 5+ years experience in medical device quality
- 2+ years experience in design assurance
- 2+ years experience in eQMS
- Experience in capital equipment manufacturing
- Working knowledge of ISO 13485
- Bachelor of Science in Engineering, life sciences or equivalent experience
- Electrical, Mechanical or Biomedical Engineering background is preferred
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Quality Assurance Manager - Morgan Hill, United States - SN&N Electronics
3 weeks ago
Description
Company Description
SN&N Electronics, Inc. is a product development firm located in Morgan Hill, CA. We partner with technology startups, Fortune 500 companies, and academic institutions to bring product and research ideas to life. By combining precision engineering, innovative hardware, and solution-driven software design and development, we transform ideas into working products and solutions that have a global impact.
Role Description:
Quality Assurance Manager has a hands-on role in implementing, improving and maintaining a Quality Management System compliant to all relevant regulatory requirements and standards. This role will work with other functional groups in the development, maintenance, and continuous improvement of SN&N quality processes. This role should embody collaboration along with excellent negotiation skills to influence internal and external partners.
Responsibilities:
Qualifications:
