| Job alert | Jobs 81 - 90 of 845 |
Manufacturing Engineer
firstPRO, Inc
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Billerica, MA, 01821
... Knowledge of FDA QSR's and ISO regulations is helpful. Education/Experience: B.S in Mechanical Engineering/Biomedical/Electromechanical Engineering with 5-10 years of experience in the Biomedical or High Volume manufacturing field. Must have ... - May 18
Senior Human Factors & Usability Engineer
Fresenius Medical Care
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Lawrence, MA, 01842
... * Responsible for HF assessments included in regulatory documents submitted to the FDA (or other regulatory bodies). * Responsible for ensuring compliance to applicable standards and guidance. * Contributes to human factors process development and ... - May 20
Automation Engineer (DeltaV)
LVI Associates
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Boston, MA, 02298
... With extensive experience in cGMP and FDA regulated industries, our team of engineers delivers innovative automation solutions aligned with industry standards. We provide professional support and expertise in Automation, Manufacturing Systems, and ... - May 13
Manager, Regulatory Affairs - IV Therapy
Fresenius Kabi US
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North Andover, MA, 01845
... * Experience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs) * Sound regulatory and scientific knowledge * Experience and proven effective collaboration in a multicultural environment * Strong ... - May 19
QA Complaint Coordinator
Mondo
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Bedford, MA, 01730
... Qualifications: Relevant work experience in an administrative capacity, ideally in a medical device company or similar industry Understanding of quality management systems, document control processes, and regulatory requirements (e.g., FDA, ISO ... - May 29
Quality Systems Analyst
Resonetics
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Nashua, NH
... Ensure work is performed in compliance with regulatory standards (e.g., FDA, ISO 13485, 21 CFR Parts 820 and 11) and internal quality requirements. Build dashboards and reports to monitor the effectiveness of the QMS. Conduct risk assessments and ... - May 10
Quality System Specialist
GForce Life Sciences
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Waltham, MA
... Understanding and working knowledge of US FDA and European regulatory requirements and GMP, and the ability to determine phase-appropriate requirements Knowledge of Regulatory Compliance and ICH Guidelines - May 17
Quality Control Inspector I
Integralife
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Gallows Hill, MA, 01970
... • Working knowledge of current Good Manufacturing Practices and familiarity with application of FDA and ISO quality standards in a government regulated industry is a plus. • Familiarity with application of FDA and ISO quality standards in a ... - May 15
Director of Quality
Lumicell
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Newton, MA, 02458
... Maintain and enhance a comprehensive quality management system (QMS) to ensure alignment with cGMP and other regulatory requirements across both clinical and commercial operations for FDA-regulated medical devices and drugs. Develop and implement ... - May 16
Electrical Engineer (Medical Device)
Intellectt Inc
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Boston, MA, 02298
... Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates ... - May 31