Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Skills
Acquisition
Auditing
Change Management
Continuous Improvement
Critical Thinking
Customer Engagement
Dashboard
KPI
Management
Job Details
We are looking for Senior Quality Engineer for our client in Santa Clara, CA
Job Title: Senior Quality Engineer
Job Type: Contract
Job Description:
Pay Range: $45.30hr - $50.30hr
- The Quality Engineer IV will provide compliance and quality system support to the Regulatory Affairs organization.
- This role focuses on audit preparedness, quality system integration, KPI reporting, and driving continuous improvement initiatives to ensure regulatory compliance across products, acquisitions, and post-approval commitments.
- Drive preparation of KPI dashboards and support Regulatory Affairs management reviews and internal metrics.
- Manage strategic programs for audit preparedness including risk identification, mitigation, and preventive actions.
- Support quality system integration for acquisitions and new product introductions.
- Identify and implement system and systemic process improvements.
- Track and maintain regulatory post-approval commitments.
- Drive quality system process improvement initiatives.
- Establish audit support for integration products.
- Improve and maintain quality system procedures including change management.
- Liaise with cross-functional partners and international affiliates to meet compliance needs.
- Participate in audit backrooms and Regulatory Affairs projects.
- Investigate nonconformances, manage CAPAs, and implement mitigations.
- Develop and implement auditing plans for critical Regulatory Affairs activities such as technical documentation, impact assessments, and archival.
- Support QMS audits and QMS integration from a Regulatory Affairs perspective.
- Maintain and report management review metrics.
- Independent working capability.
- Strong troubleshooting and critical-thinking skills.
- Ability to drive problems through resolution and implement mitigations.
- Ability to manage multiple workstreams simultaneously.
- Exposure to Medical Device US and CE regulations.
- Experience with quality systems, compliance, or Regulatory Affairs support is a plus.
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