at both sending and receiving sites. Support process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485...
Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring... and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components...
PQ submissions as required. Serves as representative to gather and interpret new and changed regulations and guidelines... submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ). Critical review of study protocols...
and implement long-term corrective and preventive actions (CAPAs). Support installation, qualification, and validation (IQ/OQ/PQ...
and reliability. Provide metrology expertise for new equipment installations, commissioning, and qualification (IQ/OQ/PQ). Participate...
protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports...
Summary : Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ...), and PQ (Performance Qualification) protocols and reports. Lead Master Validation Plan, risk assessments (FMEA), and ensure...
on international projects. What You’ll Be Doing: Run IQ, OQ, PQ, and FQ protocols to qualify products Conduct test method...
validation (IQ/OQ/PQ). Support new product development by coordinating prototype machining, providing DFM/A input...
PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies.... Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...