at key retailers, online and offline, and through distributors around the world. As the Quality System Compliance Manager..., manufacturing, and quality teams to integrate compliance considerations into early design decisions. Governance & Reporting...
to lead and mature our quality systems and regulatory readiness for AI-enabled Software as a Medical Device (SaMD) and digital... health solutions. This role sits within HDI's Regulatory & Medical Device organization. You will serve as a hands-on quality...
as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through... advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for complex cardiac...
. What you bring Required B.S./M.S. in Electrical Engineering or related discipline. 10+ years in medical device electrical..., manufacturable electronics for Class II/III devices? Can you balance rapid prototyping with production-quality PCB design...
of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro... supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) and SWFMEA development...
Job Description Summary The QA Quality Systems & Compliance Senior Manager is responsible for leading and overseeing... of progressive experience in quality assurance within pharmaceutical (preferred) and/or medical device manufacturing. Experience...
My client is an electro-mechanical manufacturer for the medical device industry and they are looking for a Quality... Assurance Manager to manage the FDA and ISO Quality Management System and ensure products are designed, developed, manufactured...
Background Preferred); med device a preferred As PMO Manager, you will lead and develop our team of Project Managers (PMs... medical device programs. Ability to translate complex technical requirements into actionable project plans while balancing...
and responsibilities for this position title. The EH&S Product Compliance Manager is responsible for ensuring that medical device... Jobs Job Description Regulatory Affairs-EH&S Product Reg. Comp. Manager Aesthetic Medical Device (WA) Job Location: Bothell, Washington, USA...
and risk mitigation. Ensure all engineering activities comply with FDA, GMP, and relevant quality system requirements... lines to ensure safe, reliable supply of life‑sustaining products. In this Job, the Sr. Engineering Manager will: Lead...
-paced, resource-lean environment while ensuring compliance with FDA design controls and quality system requirements. The... ideal candidate has 4–10 years of experience managing medical device development programs, has successfully supported new...
. The company’s IpsiHand® device is durable medical equipment that enables chronic stroke survivors to regain upper...; grounded in clinical evidence and informed by the lived experiences of patients and their families. The Medical Device Supply...
Manager, Medical Devices generates revenue utilizing a consultative selling approach and will focus on, but not exclusively..., CE marking and supply chain assessments for multi-national Fortune 500 type medical device manufacturers...
engineering support for a regulated medical‑device manufacturing environment, influencing production quality and operational... issues, and ensuring production quality and regulatory compliance. It also manages engineering projects, directs a team...
with FDA, GMP, and relevant quality system requirements. Promote Lean, Six Sigma, and continuous improvement methodologies..., maintenance, quality, and supply chain to align on production goals and risk mitigation. Ensure all engineering activities comply...
OPEN JOB: Maintenance Planner – Medical Device Manufacturing Plant LOCATION: Sumter, South Carolina **Relocation... compliance with quality systems, policies, procedures, and best practices, and all local, state, federal and safety regulations...
/Quality Compliance in a medical device industry preferred. Knowledge of electronics is preferred,... Job Description: The Sr. Complaint Specialist Investigation Lab role is responsible for medical device post-market surveillance as it...
Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias. The... a highly skilled and experienced Principal Software Engineer to join our Affera Mapping and Ablation System Software Team...
Description Kenvue is currently recruiting for a: Senior Manager, R&D Quality & Compliance What we do At Kenvue... Location: Hybrid What you will do The Senior Manager, R&D Quality & Compliance (Q&C) directs staff performing R&D Q&C...
standards of care. The Quality Compliance Manager, ECMP Site Facilitator, provides tactical support and oversight of the... site Quality and Operations leaders and may have responsibility for more than one site. The Quality Compliance Manager...