Senior Staff Clinical Quality Associate (Onsite)

Posted Yesterday
Be an Early Applicant
Fremont, CA, USA
In-Office
116K-238K Annually
Senior level
Healthtech
The Role
Lead clinical quality and compliance for neurovascular clinical research: manage quality programs, audits, inspections, vendor audits, risk controls, SOPs, corrective actions, training, and inspection readiness across global clinical activities.
Summary Generated by Built In
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.

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.

Skills 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
  • 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

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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