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Stryker Employment Company, LLC
Senior Staff Clinical Quality Associate (Onsite)
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Based on California data
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What they do
A Clinical Quality Manager ensures that the quality of the work in a clinical environment is consistent and meets government and industry standards as well as customer expectations. Verifies compliance with health and safety regulations. Coordinates all activities related to quality assurance and monitoring and revises existing processes in order to increase efficiency.
$157,377 / year median in California
Job Description
Work Flexibility:
Hybrid or Onsite 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 Travel Percentage:
30% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer- M/F/Veteran/Disability.
- Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based
- You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite
- Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid
- You can expect to regularly work in both an alternate workplace and a Stryker facility.