Global QMS Architect — Medical Devices (Hybrid)

Stryker Corporation; Portage (MI); Hybrid; USD 73,000 - 121,000; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Quality Management System Specialist to design, maintain, and improve a global QMS. This hybrid role supports regulatory approvals, quality processes, and governance across functions, including audits, training, and supplier/customer quality agreements.

The ideal candidate has a Bachelor’s degree in a related field and 3+ years in a regulated environment with knowledge of medical device regulations and quality systems change control.

Qualifications

• Bachelor’s degree in science, engineering, business, or related discipline.
• 3+ years of experience in a regulated industry environment.
• Preferred knowledge of US and international medical device regulatory requirements.
• Experience supporting quality systems such as audits, management review, quality planning, and corrective action processes.
• Experience supporting regulated information systems or quality systems change control.
• Exposure to good manufacturing and distribution practices within a quality environment.

Responsibilities

• Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances.
• Develop and update quality system processes, procedures, and documentation to reflect business needs and regulatory expectations.
• Assess and quantify quality system requirements to optimize structure, integration, and scalability.
• Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes.
• Support management review, quality planning forums, and related governance activities with data-driven inputs.
• Partner with stakeholders to ensure quality processes reflect actual operational activities, including support for new product development.
• Prepare for and support internal, external, and third-party quality system audits, including responses and follow‑up actions.
• Contribute to quality system training content and delivery to ensure effective adoption across the organization.

Skills

Quality Management Systems

Regulatory compliance

Audits and CAPA

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering/business

Job description

Stryker Corporation in Portage, MI is seeking a Senior Quality Management System Specialist to design, maintain, and improve a global QMS. This hybrid role supports regulatory approvals, quality processes, and governance across functions, including audits, training, and supplier/customer quality agreements.

The ideal candidate has a Bachelor’s degree in a related field and 3+ years in a regulated environment with knowledge of medical device regulations and quality systems change control.