- Medtronic (Santa Rosa, CA)
- …are evident on your resume.** + Requires a Bachelors Degree + Minimum of 7 years of medical device quality , regulatory or engineering experience, + Or an ... advanced degree with a minimum of 5 years of medical device quality , regulatory or engineering experience **Nice to Have** + Experience working in … more
- Molnlycke Health Care (Gothenburg, NE)
- … standards. What you'll need + 5+ years of experience in the medical device industry within Quality and/or Regulatory departments. + 10+ years of project ... Quality & Regulatory Project Manager Help...orchestrates One Molnlycke to provide our customers with world-leading medical solutions by assuring Quality and Compliance… more
- Eurofins (Boston, MA)
- …+ Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management. + Foster a culture ... to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance processes. This role… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …(or similar) is required. Master's degree preferred. + Experience in medical device Regulatory Affairs, Quality Assurance, or Research & Development ... which may impact Olympus' product portfolio. + Aggregate identified Regulatory Intelligence and perform quality checks to...activities. + Has a broad understanding of the global medical device regulatory landscape, … more
- Merck (Rahway, NJ)
- …device and/or combination product space. + In-depth knowledge of medical device development, regulatory requirements, and quality standards, with a ... and commercialization. + Provide strategic leadership in the early development of medical devices and drug- device combination products, aligning with the… more
- Integra LifeSciences (Boston, MA)
- …or related field preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other ... Technician will be responsible for supporting all activities in the Quality Control Analytical team. This role also involves supporting non-conformance… more
- West Pharmaceutical Services (Tempe, AZ)
- …biology or equivalent. + Significant experience (10+ years) in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, or a ... Sr. Quality Manager Requisition ID: 66480 Date: Dec 30,...Abilities:** + ** Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical regulations and guidelines,… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...scientific, regulatory and business issues to ensure regulatory filings are of high quality and… more
- Medtronic (Mounds View, MN)
- …of a cross-functional team. + Medical device industry experience in Quality or Regulatory . + Familiarity with these regulations: FDA 21 CFR Part 820, ... in a more connected, compassionate world. **A Day in the Life** Senior Quality Engineer - Trending and Data Analytics Careers That Change Lives At Medtronic,… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Sr. Manager, Medical Device Quality Systems, is responsible for supporting ... the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- Actalent (Santa Clara, CA)
- …Internal and External Audit Activities Skills Audit, Medical Device , quality systems management, Gap assessment, Regulatory , Data entry, Quality ... compliance, Gmp, NCR, Compliance Top Skills Details Audit, Medical Device , Quality systems Management, Gap Assessment, Regulatory Additional Skills… more
- Sanofi Group (Cambridge, MA)
- …or related engineering degree) + 6+ years' experience in medical device product development focused on quality engineering related activities. + 2 ... **Job Title:** Digital Device Quality Expert - SaMD **Location:**...Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP… more
- GE HealthCare (Aurora, OH)
- …or Pharmaceuticals + Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not ... team, you will ensure adherence to the GE HealthCare Quality Management System and regulatory requirements, including...Characteristics** + Experience in Quality Assurance or Quality Engineering within the Medical Device… more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …and efficiency. You will play a crucial part in shaping the future of medical device engineering, ensuring regulatory compliance, and fostering a culture ... processes. + Experience with complex, software-driven, electromechanical medical device products is preferred. + Familiarity with regulatory audit… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …for device launches and market entry. + Understanding of the medical device landscape, including regulatory requirements, reimbursement processes, and ... + Background in commercial strategy and leadership within the medical device industry or related field. +...Familiarity with Quality Management Systems (QMS) and Quality Assurance principles to ensure devices meet regulatory… more
- Sutter Health (West Sacramento, CA)
- …in Northern California within the Sutter Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and ... comprehensive action plans to address gaps and enable successful execution of medical device integration and technology advancement including testing, release… more
- Lilly (Indianapolis, IN)
- …Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL) + Regulatory inspection experience + Knowledge ... is $118,500 - $173,800 **Position Brand Description:** The IDM (Indianapolis Device Manufacturing) Quality Assurance Associate Director is primarily responsible… more
- Integra LifeSciences (Boston, MA)
- … Engineering/ Quality Compliance/ Quality Assurance experience in the Medical Device or similar FDA regulated industry. Integra LifeSciences is an equal ... documentation). + Knowledge of statistical sampling and analysis. + Working knowledge of medical device regulations (including FDA QSRs, ISO13485). + Ability to… more
- Vanderbilt University Medical Center (Nashville, TN)
- …Team **Job Summary:** Manages vision, roadmap, deliverables to support the growing medical device and software support needs of the enterprise. Translates ... in the future. . **KEY RESPONSIBILITIES** * Leads vision, roadmap, deliverables for medical device software and hardware. * Translates customer needs into… more
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