Quality Systems Manager
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Job Location:
Mountain View, CA - USA
Monthly Salary:
USD 145000 - 165000
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Why join AliveCor
At AliveCor we imagine a healthier world powered by access to personalized intelligent information. Were on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software millions of users have taken more than 200 million heart health measurements and counting.
Our vibrant team of people are attracted to AliveCor because they want to build something meaningful - and AliveCor delivers: every day customers tell us that weve saved lives. Join us in our mission!
The Opportunity
As a key member of our Quality team this person will provide oversight for medical device development and 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.
Job Duties and Responsibilities:
- Responsible for ensuring that AliveCors 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 AliveCors 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
Qualifications and Skills:
- 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)
- ASQ CQA certification or equivalent lead-auditor training (preferred)
Required Experience:
Manager
Key Skills
- ABAP
- Information Technology Sales
- Investment Management
- Landscape
- Maintenance
- Clinical
