Summary: Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim: E...
Roles & Responsibilities: 10+years. Experience with CSV, upgrades, enhancements, and operational support procedures. Demonstrated ability to understand, analyze and document complex business processes, translate business needs and...
Job Description: We are seeking an experienced Validation Specialist to support validation activities for Syringe Assembly Machines (SAM) in a GMP-compliant pharmaceutical environment. The ideal candidate will possess a strong understandin...
Summary : The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Qu...
Responsibilities: Develop URS, SIC and SRA for new and existing aseptic facilities and equipment. Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and ac...
Summary: Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. Demonstrated experience in tracking changes, coordinating document review...
Job Description: As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for m...
Responsibilities: Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance. Serve as a Subject Matter Expert and own Risk Ma...
Summary Mandatory - Validation experience with ERP applications / SAP / MES Experience in validating ERP/SAP/ MES Manufacturing applications Roles & responsibility Preferred tools knowledge and experience: JIRA, SAP Solution Manager, ...
Roles & Responsibilities : Create, review, and maintain detailed manufacturing documentation (process routings, work instructions, assembly instructions, control plans, etc.) for new part numbers and production processes. Support supplie...