Roles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 C...
Job Description: You are a problem solver. Complex projects or unexpected challenges are opportunities to apply your considerable abilities. Whether working independently or with a trusted team, you are always ready to tackle a project an...
Job Description: Serve as the SME for qualification of analytical equipment in a GMP manufacturing setup, ensuring compliance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11. Responsibilities: Author/execute URS, DQ, IQ, OQ, PQ protoco...
Job Description: The Supplier Quality Engineer will be responsible for managing supplier quality processes, supporting PSW activities, coordinating change management, and ensuring compliance with product and documentation requirements. Thi...
Job Description: Self-sufficient go-getter with quality mindset. Associate will be working closely with the supplier quality team to address gaps within supplier quality and distribution systems. They will be expected to pull and review d...
Responsibilities: Process Validation and IQ-OQ-PQ Experience in medical parts manufacturing experience is the key, with process validation expertise around 8 to 10 yrs experience. Protocol Review & Compliance: Study and assess Installati...
Roles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 C...
Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 1...
Roles & Responsibilities: Is a bachelor's degree Required? - Not required, but degree is preferred. I would reference the requirements that we have for our quality analysts, see below. How many years of recent experience does this person...
Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 1...
Job Description: Author/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report. Perform IQ/OQ/PQ test execution for manufacturing equipment. Experience in Test Method Va...
Responsibilities: Serve as the technical SME for qualification of analytical equipment in manufacturing setup. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 1...