Role: Quality Engineer IV
Location: Santa Clara, CA - 95054-2807
Duration: 12+ Months
Job Description
- 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
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 audit compliance needs and driving to implementation/resolution.
- Participating in audit backrooms, and
- 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 task
Management Review Metrics results