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Stryker
Senior Staff Clinical Quality Associate (Onsite)
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Based on Utah 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.
$125,929 / year median in Utah
Job Description
Stryker is hiring a
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.
- Senior Staff Clinical Quality Associate
- for our
- Neurovascular
- division. This is an
- onsite
- role based in
- Fremont, CA
- or •Salt Lake City, UT•.
- Senior Staff Clinical Quality Associate
- , you will focus on clinical quality, compliance governance, and regulatory readiness across global clinical research activities.
- 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 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.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.