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Company Contact Info
- San Diego, CA
- Cherelle Hemsley
- Phone: 8586092014
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Aerotek • San Diego, CA
Posted 8 days ago
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ESSENTIAL DUTIES AND RESPONSIBILITIES:
- This position will have the responsibility for compliance of the Quality Systems related to Training, Document Control, and Records Retention.
- Write and execute Quality Plans for Quality System process improvements.
- Responsible for the review and assessment of MasterControl release notes against business and quality requirements to determine if upgrades and/or patches are required. Present recommendations to a cross functional team. Coordinate, lead, and execute required verification and validation activities associated with changes to the system.
- Optimize processes and corresponding procedures in compliance with regulatory requirements for identifying, accessing, and maintaining internal documents and records as well as records from external sources (e.g., records required for external partners). Establish a method for organizing, filing, and retaining electronic records within the Design History Files.
- Support external and 3rd party audits by organizing and leading back room activities, responsible for the review of records to ensure regulatory and quality requirements have been met prior to being shown to the auditor.
- Responsible for investigating and documenting NCRs/CAPAs within the Quality System as well as reviewing and approving NCRs/CAPAs conducted by other departments. Responsible for review of actions to close NCRs/CAPAs, developing and conducting effectiveness verifications, and tracking the status of NCRs/CAPAs. Responsible for developing CAPA metrics as well as scheduling, leading and presenting monthly CAPA metrics to CAPA owners and Management. Identify trends, investigate adverse trends, and present solutions.
- Identify, initiate, and lead process and compliance improvement as requested.
- Performs other duties & projects as assigned.
- BS/BA degree in an Engineering or Science discipline.
- 5+ years related experience in the regulated industry
- Possess in-depth knowledgeable and experience of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDR, ISO 13485
- Strong emphasis placed on working with technical disciplines and understanding of product and process technologies
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.