Quality Engineer III

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address View email address on click.appcast.io can be reached on # View phone number on click.appcast.io.


We have Contract role Regulatory Quality Engineer for our client at Santa Clara CA Please let me know if you or any of your friends would be interested in this position.


Position Details:
Regulatory Quality Engineer- Santa Clara, CA
Location : Santa Clara, CA, 95054
Project Duration : 12+ Months of contract
Pay rate : $48/hr on W2

Description / Summary:
This role will provide quality system and compliance support to the Regulatory Affairs (RA) organization by -

• 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.
• Investigating non-conformances (e.g., CAPAs), implementing mitigations, and monitoring effectiveness of CAPAs.
• Identifying and implementing system and/or systemic processes.
• Supporting tracking and maintenance of regulatory post-approval commitments.
• Driving quality system process improvement initiatives.

Initiatives include but are not limited to:


1. Establishing audit risk mitigation activities for critical RA tasks.
2. Improving and maintaining quality system procedures (e.g., change management).
3. Liaising with cross-functional partners and international affiliates to meet compliance needs and driving to implementation/resolution.
4. Participating in audit backrooms, and / or front rooms, and
5. Participating in RA projects.


Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a must.

List of tasks:

• 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.
• Key Performance Indicator results / metrics management
• Change management (change orders for procedural updates)
• Post-Approval Regulatory Commitments management
• Support QMS audits from an RA perspective
• Support QMS Integration tasks

Skills:

• Troubleshooting
• Critical thinker
• Communication and Collaboration
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously with timely execution.

Experience:

• 5 - 7 years

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address View email address on click.appcast.io can be reached on # View phone number on click.appcast.io.

About generis tek : generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.