Quality Engineer III

Title: Quality Engineer III
Location: Santa Clara, California (100% Onsite)
Duration: 12Months
Pay Range: $50/hr to $55/hr (On W2)

We are looking for a "Quality Engineer" to join one of our Fortune 500 clients.

Job Summary:

This role will provide compliance support to the Regulatory Affairs organization.Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

Top Skills:

• Change management (change orders for procedural updates)
• Develop and implement an "auditing plan" for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
• CAPAs/Auding Finding management.
• Post-Approval Commitments management
• Support QMS audits from an RA perspective & Support QMS Integration tasks
• Management Review Metrics results

Job Responsibilities:

• Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
• Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
• Supporting quality system integration for acquisitions and new product introductions.
• Identifying and implementing system and/or systemic processes.
• Supporting tracking and maintenance of regulatory post-approval commitments.
• Driving quality system process improvement initiatives
• 5-7 years of experience
• Initiatives include but are not limited to:
• Establishing audit support for integration products.
• Improving and Maintaining the quality system procedures (e.g., change management)
• Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution.
• Participating in audit backrooms, and
• Participating in RA projects.

Skills:

• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously.

We are looking for the candidate who are eligible to work with any employers without sponsorship .

If you're interested, please click "Apply" button