Senior Staff Clinical Quality Associate

Regulatory Jobs; Fremont, Salt Lake City (CA, UT); Hybride; USD 116 000 - 238 000; Plein temps

Résumé du poste

Stryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division. This onsite/hybrid role based in Fremont, CA or Salt Lake City, UT focuses on clinical quality, compliance governance, and regulatory readiness across global clinical research activities.

As the Senior Staff Clinical Quality Associate, you will lead audits and inspections, oversee quality systems, vendor audits, and continual improvement of clinical quality programs to ensure processes, documentation, and

Qualifications

• Bachelor’s degree required.
• 7+ years in clinical quality, clinical research, QA, compliance, or related regulated field.
• 5+ years supporting quality systems, regulatory programs, audits, or inspections.
• Experience with regulated clinical studies.
• Knowledge of ISO 1415 or 21 CFR 812 or equivalent.

Responsabilités

• Manage clinical quality and compliance programs with milestones and timelines.
• Identify, assess, and communicate compliance risks and controls across functions.
• Lead internal and external audits and inspections, including preparation and follow-up.
• Support regulatory inspections of clinical studies conducted by authorities.
• Conduct vendor audits and monitor supplier compliance with quality requirements.
• Analyze deviations and implement corrective actions; update procedures.
• Develop and revise SOPs and quality documentation.
• Deliver compliance training and drive continuous improvement across the clinical organization.

Connaissances

Clinical quality

Regulatory compliance

Audits & inspections

Vendor audits

Formation

Bachelor’s degree

Description du poste

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

• Knowledge of ISO 14415 or 21 CFR 812 or equivalent

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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.