compliance Complaint handling and post-market surveillance Validation (IQ/OQ/PQ) Regulatory compliance strategy... protocol development (IQ/OQ/PQ). Experience with electronic QMS systems preferred. Ability to operate effectively...
resources in the equipment specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources to assess the...
acquisition, installation and qualification of production equipment and tooling, including writing the IQ, OQ, PQ documentation...
, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements. Coordinate...
experience. Orthopaedic experience preferred. Expertise in FMEAs and IQ, OQ, PQ validation. Strong understanding of regulatory...
. Perform and analyze IQ, OQ, PQ qualifications and other validation activities. Collaborate with cross-functional teams... of experience in process validation (medical device experience required;not pharma). Hands-on experience with IQ, OQ, PQ and FMEAs...
Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV). Collaborate...
quality. Ensure equipment qualification, process validation (IQ/OQ/PQ) and process control plans are implemented...
activities for construction projects. Develop Cx protocols, URSs, SOPs, IQ/OQ activities, and PQ for mechanical and utility...
and preventive actions (CAPA) and writing validation reports (IQ/OQ/PQ). Solid knowledge of GD&T, PFMEA and Control Plans...