Job description
we are seeking a highly skilled quality manager to lead our quality initiatives and ensure compliance with regulatory standards.
the ideal candidate will have extensive experience in quality management, leadership, and problem-solving techniques. They will be responsible for developing, implementing, maintaining, and measuring the effectiveness of our quality system.
* production and distribution product quality matters
* set quality kpis for production and distribution
* call and manage tj production stop in coordination with vp global operations quality
* ensure continuous alignment of learning and ways of working across sites
* ensure compliance with production and distribution standards in following qms tj
* ensure compliance with quality standards in demant following qms-tj
* ensure compliance with regulatory standards in demant following qms-tj
* create and maintain the yearly budget process (budget vs actual balance)
* plan training for quality employees
* provide input for management review according to hiqms
* capa approver and qa representative
* validation approver
* allocate quality resources efficiently to ensure optimal operational engagement
* drive quality requirements and awareness in tijuana
* escalation model followed for adverse events
* local quality management system representative on behalf of global quality
* coordinate activities related to maintaining and improving the quality management system
* supervise corrective and preventive actions
* prepare and host external audits (customer, notified body)
* comply with and steer the internal audit plan
key responsibilities: production and distribution product quality matters, set quality kpis for production and distribution, call and manage tj production stop, ensure continuous alignment of learning and ways of working across sites, ensure compliance with regulatory standards
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required skills and qualifications
we are looking for a candidate with:
* engineering degree
* work experience in medical devices as quality manager
* demonstrated leadership and supervisory experience
* problem solving techniques (5 whys, 8d, ishikawa, dmaic)
* fully bilingual (spanish and english) with effective organizational and communications skills
* strong stakeholder management
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benefits
our company offers:
* life insurance
* meals
* savings fund
* transportation
* uniform
* gym membership
* medical expenses insurance
* benefits in accordance with lft
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additional roles
opportunities for career growth and development include:
* quality control engineer
* quality control supervisor
* senior accounting manager
* senior operations manager
* senior technical program manager