Quality Systems Manager

AliveCor•Mountain View, CA

About The Position

As a key member of our Quality team, this person will provide oversight for medical device development and commercialization. In this role, you will collaborate with stakeholders across Regulatory, Product Management, and Marketing to ensure our Quality Management System remains compliant with global requirements, including MDSAP and EU MDD/MDR. This is a high-impact opportunity for a detail-oriented leader dedicated to maintaining the highest standards of safety and excellence in the medical industry.

Requirements

Bachelors’ degree in Science, Technology or Engineering
4-6 years’ experience in medical device quality systems management
Strong understanding of ISO 13485:2016, 21 CFR 820, MDSAP country specific requirements
Ability to manage projects: organized, independent, and results-oriented; perform and execute job responsibilities with high level of accuracy on a daily basis
Strong analytical and communication skills, strong team ethic, and attention to detail
Process-oriented thinking
Demonstrated competence documenting technical information and communicating it to others
Strong work experience in a Document Control, QMS Management, Supplier Management, and/or Training Records Administration function in medical device (preferred)

Nice To Haves

ASQ CQA certification or equivalent lead-auditor training (preferred)

Responsibilities

Responsible for ensuring that AliveCor’s quality system is compliant to applicable regulations, and national and international quality standards;
Develop and update QMS procedures and work instructions to be compliant, effective and efficient;
Manage and maintain an effective document and records management system and ensure these systems are maintained in a validated state;
Coordinate training plans, records, and files to ensure they are properly maintained;
Maintain AliveCor’s database of national and international standards including gap assessments
Maintain annual quality plans and manage quality system projects;
Manage internal and external audits, calibration, periodic reviews, NC and CAPA reviews;
Coordinate and maintain Management Review Meetings;
Manage supplier management and purchasing controls processes, review suppliers' performance, conduct supplier audits and organize annual supplier performance reviews
Create and use metrics to track, trend and report performance of quality systems
Promote a culture of quality throughout AliveCor
Other Quality duties as assigned