Senior Staff Clinical Quality Associate (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 is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division. This is an onsite role based in Fremont, CA or Salt Lake City, UT.

As the Senior Staff Clinical Quality Associate, you will focus on clinical quality, compliance governance, and regulatory readiness across global clinical research activities. You will provide oversight of quality systems, compliance programs, audits, inspections, and clinical processes to ensure clinical services, documentation, and operations align with applicable regulations and quality standards. You will work across functions to identify risks, strengthen controls, and support the continuous improvement of clinical quality programs.

This role provides quality and compliance oversight for clinical research activities, ensuring processes, documentation, systems, and vendor operations remain compliant, inspection‑ready, and aligned with global regulatory and quality requirements.

What you will do

• 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

What you need

Required

• Bachelor’s degree

• Minimum 7 years of experience in clinical quality, clinical research, quality assurance, compliance, or a related regulated healthcare or life sciences field

• Minimum 5 years of experience supporting quality systems, regulatory compliance programs, audits, or inspections

• Experience supporting clinical studies conducted within a regulated environment

Preferred

• Experience in medical device, pharmaceutical, biotechnology, or clinical research industries

• Experience participating in regulatory inspections and audit readiness activities

• Experience developing and maintaining standard operating procedures and quality system documentation

• Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or comparable quality or compliance certification

• US5: $115,600 - $192,600 USD Annual
• US30: $143,100 - $238,400 USD Annual