Quality Assurance Manager - Medical Devices

Stryker; Ventura (CA); Sur place; USD 113 000 - 188 000; Plein temps

Résumé du poste

Stryker Group is seeking a Manager, Quality Assurance for the TMJ portfolio in Ventura, CA. This onsite role leads QA activities across site operations, collaborating with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure compliant products and processes.

You will develop a QA team, manage audits and CAPA, and drive continuous quality improvements while aligning with business objectives and regulatory requirements.

Qualifications

• Bachelor's degree in engineering, quality, life sciences, manufacturing, or related field.
• 6+ years in technical, manufacturing, quality, or engineering in regulated industry.
• 3+ years leading teams or quality projects.
• Experience in regulated manufacturing with FDA or international quality standards.
• Experience supporting quality systems, audits, corrective actions, and improvements.

Responsabilités

• Lead and develop a team of quality professionals, establishing objectives and quality-focused practices.
• Partner with manufacturing to ensure products meet quality, regulatory, and company requirements.
• Oversee quality system activities including CAPA, change management, validation, investigations, and acceptance.
• Manage regulatory, notified body, customer, and internal audits, ensuring readiness and timely resolutions.
• Develop, monitor, and report quality metrics and use trends to identify improvements.
• Lead quality communications regarding holds, investigations, and field actions with cross-functional teams.
• Implement training programs on regulatory requirements and compliance.
• Support supplier quality activities, continuous improvements, and strategic quality planning.

Connaissances

Team leadership

Quality assurance

Regulatory compliance

Audits

Process improvement

Formation

Bachelor’s degree in Engineering/Quality/Life Sciences/Manufacturing

Description du poste

Stryker Group is seeking a Manager, Quality Assurance for the TMJ portfolio in Ventura, CA. This onsite role leads QA activities across site operations, collaborating with Operations, Global Quality, Regulatory Affairs, and suppliers to ensure compliant products and processes.

You will develop a QA team, manage audits and CAPA, and drive continuous quality improvements while aligning with business objectives and regulatory requirements.