Title: Inspector, QC
Location: Temecula, California
Duration: 6 Months
100% Onsite
shift - 6am -2:30pm
Summary
Responsible for ensuring compliance with all applicable Corporate and Divisional procedures, Quality System requirements, and regulatory expectations. Performs detailed quality assurance review and line support activities for Relabeling, Addendum, and related production documentation. Ensures complete and accurate review of LHR/eLHR, SAP transactions, and controlled documents while supporting Engineering, maintaining audit readiness, and promoting continuous improvement within the department.
Essential Duties & Responsibilities
- Performs comprehensive QA reviews of LHR/eLHR, SAP transactions, and related documentation to verify accuracy, completeness, correct document revision use, and procedure adherence.
- Audits materials, documentation, components, and line activities through visual checks, sampling, system verification, and comparison to specifications.
- Supports reduction of documentation and process errors through thorough review, timely issue escalation, and consistent adherence to established quality practices.
- Provides daily line support to Relabeling and Addendum operations, ensuring correct labeling, traceability, and documentation practices. Supports approval of required training holds.
- Assists Engineering with assigned subtasks including demonstrations, scrapping, AQL sampling, testing of SAP/LHRBM or document changes, and support of other technical evaluations as required.
- Contributes to documentation accuracy and continuous improvement by identifying process or documentation enhancements and supporting Change Order updates. Assists with assigned document updates and collaborates on development of controlled documents.
- Executes SAP transactions and inventory movements accurately. Handles and documents discrepant materials in accordance with approved dispositions and all applicable procedures.
- Supports internal and external audits by ensuring documentation is complete, organized, and available. Maintains full audit readiness through consistent compliance with procedural and documentation requirements.
- Supports Quality, Operations, and Engineering with activities related to COA requests, ICS signature requests, retains management.
- Maintains personal accountability for schedule adherence, accurate timecard entry, completion of required training, safe work practices, and participation in team activities such as daily stretches.
- Provides safety recommendations or near miss submissions and actively participates in sustaining a culture of safety and compliance.
- Achieves and maintains required certifications including QCRI, Relabeling, Addendum (if assigned), and QA Review recertification. Supports JI Assessor duties and other assigned quality responsibilities.
- Performs additional duties as required in support of Divisional initiatives, Quality Management System objectives, Environmental Management System requirements, and other cross functional business needs.
Knowledge, Skills & Competencies
- Strong attention to detail with the ability to perform accurate, complete, and compliant documentation review in a regulated environment.
- Working knowledge of SAP, LHR/eLHR systems, AQL sampling methods, and document control practices.
- Ability to understand and apply procedures, material specifications, drawings, and regulatory standards.
- Effective communication skills with the ability to convey findings, collaborate with cross functional teams, and support training activities.
- Familiarity with medical device regulatory frameworks such as ISO 13485 and 21 CFR 820 preferred.
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.
