Quality Engineer

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Smriti Kumari 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 Quality Engineer for our client at Santa Clara, CA . Quality Engineer - Santa Clara, CA Project Duration : 10+ Months of contract Pay Rate : $45/hr on W2 Description / Summary This role will provide compliance support to the Regulatory Affairs organization by – a. Driving preparation of Client 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 non conformance (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 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. Post-Approval Commitments management Support QMS audits from an RA perspective Skills Critical thinker Ability to drive a problem through resolution and implement mitigations. Ability to handle multiple streams simultaneously. #J-18808-Ljbffr Generis Tek Inc