- Abbott (Burlington, MA)
- …representative to ensure design controls, risk management, cybersecurity, and verification/ validation are planned and executed to deliver safe, effective Class ... III medical devices worldwide. You will operate within a global quality system aligned to FDA 21 CFR Part 820 (transitioning to QMSR aligned with ISO 13485), EU MDR… more
- Cardinal Health (Mansfield, MA)
- …according to cGMP principles. + Perform analytical method verification, validation and analytical method transfer protocols following the regulatory requirements ... (ICH, USP and FDA ). + Perform investigations of Out of Specification (OOS)...guidelines, preferred + Experience with analytical method verification and validation following regulatory guidelines, preferred + Experience with analytical… more
- Mitsubishi Chemical Group (Wilmington, MA)
- …leadership experience + Strong knowledge of cGMP regulations, quality systems, and validation requirements + Proven experience supporting FDA inspections and ... product and raw material release, batch record review, investigations, audits, CAPA, validation , and training. This position also serves as the ISO Management… more
- ThermoFisher Scientific (Plainville, MA)
- …seeking a professional with in-depth knowledge of the commissioning, qualification and validation lifecycle. As part of the PSG global engineering team, this remote ... regulations, and requirements. KEY RESPONSIBILITIES + Ensuring site adherence to global validation policies and procedures + High level support for Capital Project … more
- J&J Family of Companies (Danvers, MA)
- …Quality to ensure smooth design transfers and robust manufacturing readiness. + ** Validation & Verification** + Plan and execute IQ/OQ/PQ activities for equipment, ... processes, and software where applicable. + Develop and approve validation protocols and reports; ensure traceability to user needs and regulatory requirements. +… more
- Datavant (Boston, MA)
- …regulated data services and software. This includes oversight of software validation , privacy compliance, supplier qualification, and audit readiness. You will also ... responsible for core functions such as CAPA, internal audits, validation , and supplier monitoring. + Serve as the primary...all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). +… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …in alignment with FDA and QSR standards. + Develop and execute validation plans for service test systems and methods. + AUTOMATION & WORKFLOW IMPROVMENT + ... TestStand, Python, or equivalent frameworks. + Establish test requirements, strategy, and validation approaches for new and existing test methods. + Troubleshoot and… more
- Hologic (Marlborough, MA)
- …assuring product inputs are clearly identified, and design verification and validation activities are compliant. + Manage and troubleshoot product, process, and ... and prototype fixtures, develop test methods, and execute protocols for verification/ validation activities. + Maintain accurate records and documentation per FDA… more
- Oracle (Boston, MA)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... requirements map to user needs and validation meets usability and human factors standards. . Lead...Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). .… more
- J&J Family of Companies (Danvers, MA)
- …cardiac support therapies. This role owns scale-up, process validation , root-cause investigations, safety, regulatory compliance, and continuous improvement ... process mapping, equipment qualification, and line layout optimization. + ** Validation , Qualification & Qualification Life Cycle** + Lead IQ/OQ/PQ strategies… more