Hiring: Senior Staff Clinical Quality Associate (Onsite) Company: Stryker Location: Fremont, CA Job Posted Time: 2026-09-17 04:22:45 Employment Type: On-site Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job Experience: •7 years of experience in clinical quality, clinical research, quality assurance, compliance, or a related regulated healthcare or life sciences field •5 years of experience supporting quality systems, regulatory compliance programs, audits, or inspections •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 Required Skills: •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 Qualifications: •Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or comparable quality or compliance certification Compensation: •$115,600 - $192,600 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!