Global QMS Lead - Medical Device Compliance & Improvement

Regulatory Jobs; Portage (MI); Hybrid; USD 73,000 - 121,000; Full time

Job summary

Stryker Corporation in Portage, Michigan seeks a Senior Quality Management System Specialist to design, maintain, and improve a global QMS supporting regulatory approval and business growth. You will collaborate across functions to ensure compliant, practical, and scalable quality processes and documentation.

The role covers internal/external audits, supplier quality, quality planning, and QMS change control, with a strong emphasis on cross‑functional alignment and continuous improvement.

Qualifications

• Bachelor’s degree in science, engineering, business, or related discipline.
• 3+ years of experience in a regulated industry environment.
• Knowledge of U.S. and international medical device regulatory requirements.

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

Regulatory knowledge

QMS audits

Quality systems

Good manufacturing practices

Education

Bachelor's degree

Job description

Stryker Corporation in Portage, Michigan seeks a Senior Quality Management System Specialist to design, maintain, and improve a global QMS supporting regulatory approval and business growth. You will collaborate across functions to ensure compliant, practical, and scalable quality processes and documentation.

The role covers internal/external audits, supplier quality, quality planning, and QMS change control, with a strong emphasis on cross‑functional alignment and continuous improvement.