Senior Staff Clinical Quality Associate (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.

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

• Bachelors 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