Senior Clinical Quality Leader - Neurovascular (Onsite)

Stryker Group; Fremont (CA); On-site; USD 115,600 - 238,400; Full time

Job summary

Stryker Group is seeking a Senior Staff Clinical Quality Associate for its Neurovascular division. This onsite role is based in Fremont, CA or Salt Lake City, UT, and focuses on clinical quality, compliance governance, and regulatory readiness across global clinical research activities.

You will oversee quality systems, audits, and inspections, drive risk-based improvements, and ensure processes and documentation meet global regulatory standards. Strong leadership is required.

Qualifications

• Bachelor’s degree is required.
• 7+ years in clinical quality, clinical research, quality assurance, compliance, or related regulated healthcare or life sciences field.
• 5+ years supporting quality systems, regulatory compliance programs, audits, or inspections.

Responsibilities

• Manage clinical quality and compliance programs, establishing milestones, resource plans, and delivery timelines to support on-time execution.
• Identify, assess, and communicate compliance risks and control strategies to stakeholders across clinical, quality, and business functions.
• Lead internal and external audit and inspection activities, including preparation, execution, follow-up actions, and documentation management.
• Participate in regulatory inspections, including inspections of clinical studies conducted by regulatory authorities.
• Conduct vendor audits and inspections, maintain audit schedules, and monitor supplier compliance with quality requirements.
• Analyze process deviations, determine corrective actions, and update procedures to maintain compliance with applicable regulations and standards.
• Develop, maintain, and revise standard operating procedures, work instructions, and quality documentation.
• Deliver compliance training, provide guidance on clinical quality requirements, and support continuous improvement initiatives across the clinical organization.

Education

Bachelor’s degree

Job description

Stryker Group is seeking a Senior Staff Clinical Quality Associate for its Neurovascular division. This onsite role is based in Fremont, CA or Salt Lake City, UT, and focuses on clinical quality, compliance governance, and regulatory readiness across global clinical research activities.

You will oversee quality systems, audits, and inspections, drive risk-based improvements, and ensure processes and documentation meet global regulatory standards. Strong leadership is required.