Quality Engineer

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 Required What you need 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 Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. #J-18808-Ljbffr