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Job Requirements of Quality Engineer IV:
-
Employment Type:
Full-Time
-
Location:
Santa Clara, CA (Onsite)
Do you meet the requirements for this job?
Quality Engineer IV
Generis Tek Inc.
Santa Clara, CA (Onsite)
Full-Time
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address can be reached on #
We have Contract role 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:
Quality Engineer - Santa Clara, CA
Location : Santa Clara, CA - 95054
Project Duration : 12+ Months Contract
Pay Rate : $45/hour on W2
Job Description:
Description / Summary:
This role will provide compliance support to the Regulatory Affairs organization by –
a. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
b. 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.
c. Supporting quality system integration for acquisitions and new product introductions.
d. Identifying and implementing system and/or systemic processes.
e. Supporting tracking and maintenance of regulatory post-approval commitments.
f. Driving quality system process improvement initiatives.
Initiatives include but are not limited to:
1. Establishing audit support for integration products.
2. Improving and maintaining the 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
5. Participating in RA projects.
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.
List of tasks:
• 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
Skills:
• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously.
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address can be reached on #
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.
630-576-1932
.We have Contract role 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:
Quality Engineer - Santa Clara, CA
Location : Santa Clara, CA - 95054
Project Duration : 12+ Months Contract
Pay Rate : $45/hour on W2
Job Description:
Description / Summary:
This role will provide compliance support to the Regulatory Affairs organization by –
a. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
b. 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.
c. Supporting quality system integration for acquisitions and new product introductions.
d. Identifying and implementing system and/or systemic processes.
e. Supporting tracking and maintenance of regulatory post-approval commitments.
f. Driving quality system process improvement initiatives.
Initiatives include but are not limited to:
1. Establishing audit support for integration products.
2. Improving and maintaining the 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
5. Participating in RA projects.
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.
List of tasks:
• 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
Skills:
• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously.
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address can be reached on #
630-576-1932
.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.
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