Quality Engineer - Medical Device Manufacturer
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
Management System. Support execution of process and equipment validations IQ/OQ/PQ/MVP/TMV). Create process documentation...
: Experience with IQ/OQ/PQ, Gage R&R, and capability studies (Cp, Cpk). Familiarity with PLC programming (e.g., Siemens, Allen...
strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards. Lead the technical execution acquisition... in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. Communication Skills: Strong ability...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
), and Performance Qualification (PQ). Interfaces with appropriate customer contacts to clarify customer requirements Determines...
School/GED and at least 2 years (BA is PQ only) in associate degree in industrial or maintenance technology OR at least 2...
(21 CFR Part 820, GxP, CSV) and IQ/OQ/PQ testing protocols for validated systems. Experience with ERP systems, SaaS...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...