Senior QMS Specialist - Global Medical Devices (Hybrid)

Stryker; Portage (MI); Hybride; USD 73 000 - 121 000; Plein temps

Résumé du poste

Stryker in Portage, Michigan is seeking a Senior Quality Management System Specialist. Hybrid work arrangement supported, focused on designing, maintaining, and improving a global QMS to enable regulatory approvals and business growth. You will collaborate across functions and contribute to audits, training, and continuous improvement.

The role requires a bachelor’s degree and 3+ years in a regulated environment, with preference for knowledge of medical device regulations and change control.

Qualifications

• Bachelor’s degree in science, engineering, business or related field.
• 3+ years in a regulated industry environment.
• Knowledge of medical device regulations is preferred.

Responsabilités

• Support and maintain a compliant Quality Management System aligned with global medical device regulations.
• Develop and update quality system processes, procedures, and documentation.
• Assess and quantify quality system requirements to optimize structure and scalability.
• Identify and implement continuous improvement opportunities for quality processes.
• Support governance activities with data-driven inputs.
• Partner with stakeholders to reflect operational activities in quality processes.
• Prepare for internal, external, and third-party quality system audits and follow-up actions.
• Contribute to quality system training content and delivery.

Connaissances

Quality management

Regulated industry experience

Cross-functional collaboration

Audits support

Formation

Bachelor's degree in science/engineering/business

Outils

Quality systems change control

Audit management systems

Description du poste

Stryker in Portage, Michigan is seeking a Senior Quality Management System Specialist. Hybrid work arrangement supported, focused on designing, maintaining, and improving a global QMS to enable regulatory approvals and business growth. You will collaborate across functions and contribute to audits, training, and continuous improvement.

The role requires a bachelor’s degree and 3+ years in a regulated environment, with preference for knowledge of medical device regulations and change control.