Quality Systems Manager

• 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

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)

The annual base salary range for this position is $125,000 – $155,000.  This range represents the good faith estimate of the salary or hourly wage AliveCor reasonably expects to pay for this position at the time of hire. The final compensation offer will be determined based on several factors, including geographic market rates, the candidate’s years of relevant experience, and specialized industry-specific expertise. In accordance with California law, this range is specific to the role’s responsibilities and does not include potential bonuses, equity, or benefits, which may also form part of the total compensation package.