- Integra LifeSciences (Braintree, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Olympus Corporation of the Americas (Westborough, MA)
- …designinputs, product design implementation, verification testing and supporting design validation studies. The ideal candidateis a hands-on technical leader with ... and Product Requirements. + Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements andapplicable… more
- J&J Family of Companies (Danvers, MA)
- …on Abiomed delivery forecasting + Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier + Partner with internal ... ERP systems (SAP preferred) + Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports required. Experience designing and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive ... key technical role is responsible for change controls, manufacturing process validation , device product complaints, regular review of DHF, and post-market… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to preclinical and clinical biomarker assay development and validation . For more information on CMC, click here ... leadership for Takeda preclinical and clinical biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …departments with the day-to-day issues relating to supplier certification, validation and quality. Maintain quality systems associated with supplier management. ... with reviews of supplier performance data, in evaluation and validation of supplier change requests, generates brokerage component MCOs...with standards and regulations such as ISO13485, IS09001, and FDA 21 CFR Part 820. + Must be currently… more
- Hologic (Marlborough, MA)
- …ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant. + Address technical and project-based ... controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams. **Qualifications:** +… more
- Astellas Pharma (Westborough, MA)
- …+ Design and perform testing in support of method transfer/ validation /qualification/verification + Review/authorize data and perform analysis and interpretation of ... and trends + Design and/or participate in method development; equipment qualification/ validation studies; deviation and OOS investigations + Perform QC lab support… more
- Hologic (Marlborough, MA)
- …standards for safety, effectiveness, and innovation. **Knowledge:** + Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 ... + Thorough knowledge of design control processes, verification and validation planning, and requirements traceability. + Familiarity with Good Laboratory… more
- Teleflex (Mansfield, MA)
- …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more