Title: Quality Engineer III
Location: Santa Clara, CA
Duration: 12 Months
100% Onsite
Job Summary
This role will provide compliance support to the Regulatory Affairs organization.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.
Top Skills
- 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
Job Responsibilities
- 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
- 5-7 years of experience
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 compliance needs and driving to implementation/resolution.
- Participating in audit backrooms, and
- Participating in RA projects.
Skills
- Independent
- Troubleshooting
- Critical thinker
- Ability to drive a problem through resolution and implement mitigations.
- Ability to handle multiple streams simultaneously.
Consultants Eligible Benefits Upon Waiting Period
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
