Director of Design Assurance - Medical Devices
$167.4k - $297.6kMary Dickson
Mary Dickson is seeking a Director of Design Assurance located in Newark, DE (Hybrid). This role entails strategic leadership, managing the Design Assurance team, and ensuring compliance with FDA regulations. The ideal candidate will have a strong technical background, with at least 12 years of relevant experience in the field. Responsibilities include overseeing product development activities and promoting continuous improvement in design and quality processes. A competitive salary range of $167,400 - $297,600 is offered, along with bonus eligibility, depending on qualifications and experience. #J-18808-Ljbffr Mary Dickson
- Director, Design Assurance Location: Newark, DE (Hybrid). Responsibilities Strategic Leadership Direct the Design Assurance organization to support... ..., especially Design Control requirements, ISO 13485, and Medical Device Directive. Familiarity with ISO 14970, IEC 60601, IEC 623...Medical device
- Hologic, Inc. in Newark, Delaware is looking for a Lead Design Assurance Engineer to ensure compliance and quality in medical device development. This role involves defining design requirements, overseeing verification processes, and driving continuous improvement initiatives...Medical device
- Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management...Medical device
- The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls...Medical device
- ...Distribution Quality Assurance SpecialistThe Distribution Quality Assurance Specialist at Hologic is responsible for ensuring the quality... ...S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systemsExperience in root cause analysis, risk...Medical deviceWork at office
- ...passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist... ...a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare...Medical device
- ...parts. Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function,... ...methodologies to optimize processes. Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001,...Medical device
- ...Quality System Regulations, ISO 13485, Medical Device Directive, Medical Device Regulation, risk... ...knowledge of technical quality assurance and control systems, including standards... ...and inspire senior leaders, including Directors, and manage large global teams.Strong analytical...Medical device
$30 - $33 per hour
...inspecting incoming materials to ensure quality and compliance with specifications. Ideal candidates should have experience in medical device quality inspection, familiarity with inspection tools, and strong documentation skills. The position offers a pay rate between...Medical deviceHourly payFlexible hours- The Quality Design Engineer II is responsible for executing design changes, product enhancements... ...projects, including related testing, assuring product inputs are clearly identified,... ...· At least 3 years experience, in a medical device process and/or product development...Medical device
- ...seeking a Senior Software Engineer (C#/ .NET, Full Stack) to design, develop, troubleshoot, and debug software for new and existing... ...as part of a team developing user-facing applications for medical devices related to breast and skeletal health. This team currently works...Medical deviceFull timeLocal area
- ...the development of advanced medical imaging systems and electromechanical... ...owners to support the design, integration, verification, and... ...teams and system quality assurance through concept, implementation... ..., ideally within the medical device field.Experience with systems...Medical device
- ...operating procedures.Awareness of FDA-regulated environments and medical device quality standards (preferred).Skills:Proficient in Microsoft... ...collaboration.High attention to detail and focus on quality assurance processes.Ability to follow written procedures and maintain...Medical deviceWork at office
- Hologic is a global medical technology company focused on women’s health... ...producing life-saving medical devices.Job Summary:Product Quality... ...and leadership.Manage design and process change projects, including... ...role on critical tasks to assure appropriate and timely completion...Medical deviceLocal area
- ...pharmaceutical clients. In the Quality Assurance role, you will put your... ...and inspections to Study Directors, Principal Investigators,... ...pharmaceutical, biotechnology and medical device companies with their drug... ...DelawareInternal committees designed with the needs and enjoyment...Medical devicePermanent employmentTemporary workFor contractorsH1bWork at officeLocal areaWorldwideVisa sponsorship
$25 - $31 per hour
...checks. Reviews and releases Device History Records. May assist with... ...Safety shoes required in designated areas May work with high voltage... ...years preferred ~ Quality assurance or manufacturing experience... ...Experience in FDA-regulated medical device environment beneficial...Medical deviceTemporary workWork at officeShift workDay shiftAfternoon shift$141k - $205k
Terumo Medical Corporation (TMC) develops, manufactures, and markets... ...of high-quality medical devices used in a broad range of applications... ...System Lifecycle definition, design, development, integration,... ...including engineers, quality assurance, and production staff, to...Medical deviceTemporary workWorldwide$30 - $33 per hour
...inspections. Maintain material status and inventory control. Support GMP and quality system requirements. What We're Looking For Medical Device quality inspection or manufacturing experience. Experience using inspection tools such as calipers, micrometers, gauges, scales...Medical deviceHourly payContract workMonday to FridayFlexible hours- ...Medical Assistant PRN Location US-DE-Newark Job ID... ...regulations Complete quality assurance activities on equipment and medical devices as well as testing processes used... ...This job description is not designed to cover or contain a comprehensive...Medical deviceDaily paidReliefWork at officeLocal areaImmediate start
- ...lives of the patients you serve. The Medical Support Specialist (MSS) is... ...state regulations * Complete quality assurance activities on equipment and medical devices as well as testing processes used... ...This job description is not designed to cover or contain a comprehensive...Medical deviceReliefWork at officeLocal areaImmediate start
- ...debugging at the low level Motor control or board control experience 10+ years of experience Background in automotive, aerospace, or medical device industries Desired Skills and Experience:Linux alongside microcontroller development End-to-end product development experience...Medical devicePermanent employmentFull time
$110k
...Specialist to join a growing Quality & Regulatory team supporting medical device products. This is an exciting opportunity to play a critical... ...discipline preferred. 5+ years of experience in Quality Assurance, Regulatory Affairs, Supply Chain, or another regulated environment...Medical deviceFull timeMonday to FridayFlexible hours- ...must clearly document results.Ensure that design, implementation, test, and maintenance... ...the ClientThis client is a leading medical device manufacturer operating across the U.S.,... ...employs manufacturing technicians, quality assurance professionals, receiving inspectors,...Medical deviceWork at officeWork visaShift workDay shift
$117.77k - $161.93k
...the enterprise product delivery process. The role requires 7+ years in process improvement, especially within the medical device industry. You will design and evolve delivery frameworks, partner with stakeholders, and drive continuous improvement. This position offers...Medical device- Highbrow LLC in Newark, Delaware, seeks a Senior Embedded Firmware Engineer to advance a safety-critical medical device. The role focuses on maintaining and enhancing a mature C++ codebase with heavy template usage, real-time 2-3 axis motor control, and CAN bus communications...Medical device
- ...passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to... ...understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation...Medical device
- ...Senior Electrical Engineer, NPD to help design and advance the electronics behind our industry... ...that directly support life‑saving medical technology used in breast and skeletal health... ...).Experience in an FDA‑regulated medical device or similarly regulated industry is a plus...Medical device
$85.2k - $133.3k
.... The ideal candidate should possess a Technical Bachelor’s Degree and relevant experience in QMS, particularly in a regulated medical device environment. Compensation is competitive, with an annual salary range of $85,200-$133,300 plus bonuses. #J-18808-Ljbffr Mary DicksonMedical device- ...a Senior Regulatory Affairs Product Associate for the Peripheral Business Group to drive regulatory strategies for implantable medical devices, manage global submissions, and partner with cross-functional teams throughout the product lifecycle. This remote role requires...Medical deviceRemote job
- ...Newark, DE We're supporting our client in the search for a highly skilled Senior Embedded Firmware Engineer to join a critical medical device development team in Newark, Delaware. This role focuses on maintaining and enhancing a mature, safety-critical embedded firmware...Medical deviceContract work
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