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Spectraforce Technologies is Hiring a Quality Engineer Near Santa Clara, CA
Location: Santa Clara, CA
Duration: 6 Months
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 audit 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:
* RA Change Requests Tracking and Closure
* Change management
* 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.
CPRA: Notice to California Applicants: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting .
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Full Time
$121k-143k (estimate)
04/28/2024
06/27/2024
spectraforce.com
Raleigh, NC
500 - 1,000
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