QC INSPECTOR - PA2025

Job Title: Inspector, QC
Location (On-site, Remote, or Hybrid?): Temecula, CA (onsite)
Working hours:  6:00AM - 2:30PM
Total hours: 40
 

Position 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.