Verification & Validation Process and Equipment Validation (e.g. IQ/OQ/PQ) Product Quality Architecture (PQA) Innovation...
as materials are depleted. Maintains production, efficiency and quality records Other duties as assigned. Process Quality (PQ...
Verification & Validation Process and Equipment Validation (e.g. IQ/OQ/PQ) Product Quality Architecture (PQA) Innovation...
and adhere to GMP practices, ISO 13485, and FDA regulations (e.g., 21 CFR Part 820);support validations (IQ/OQ/PQ) and audit... environment;medical device or life sciences preferred. Experience with MES validation (IQ/OQ/PQ). Minimum 2 years under GMP...
Kia North America Ownership Experience - Product Quality (PQ) in supporting PQ Data Analytics Team and Service Engineering..., such as monthly top issues review, quarterly comeback analysis, monthly PQ operation reporting, and monthly quality information report...
), and Performance Qualification (PQ) for manufacturing and laboratory equipment Conduct Configuration Specification Verifications... validation protocols including Validation Plans, URS, FRS, IQ/OQ/PQ, RTM, and Validation Summary Reports Ensure compliance...
that involve: Process Mapping, Manufacturing Process Instructions, DOE and Process Instructions, OQ/PQ Protocols and Reports, IQ...
Quality prospective. Support transfer projects and Supplier localization projects. Support IQ, OQ, PQ and PPAP processes...
, executing, and documenting IQ/OQ/PQ and component/process qualifications. Reviewing supplier documentation such as FAIs, pFMEAs... of quality experience in a regulated industry (medical devices strongly preferred). Hands-on knowledge of IQ/OQ/PQ, FMEAs...
, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated... with all departments. Required Skills & Competencies Medical Device Validation (IQ, OQ, PQ) Statistical Process Control (SPC...