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
- The Distribution Quality Assurance Specialist at Hologic is responsible for ensuring the quality and compliance of distribution processes... ...S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systems Experience 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- ...Healthineers is seeking an experienced Mechanical Engineer to join our Product Engineering team, leading design and development of complex subsystems for next-generation medical devices. You will guide concept through production, performing analyses and design reviews to ensure...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 deviceWork at officeLocal areaWork from homeFlexible hours1 day per week
- ...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
- ...quality engineering support for on-market medical devices. This role will be responsible for... ...where applicable.Lead project to implement design or process change including drawing update... ...leadership role on critical tasks to assure appropriate and timely completion/resolutionAbility...Medical device
- ...Action, CAPA, processes and broader quality assurance operations. This role will partner... ...a regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated... ....Ability to present materials to director-level leadership.Understanding of statistics...Medical device
$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- 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
- ...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
- ...passionate and experienced engineer who will design, develop, and maintain high-quality... ..., Marketing, Manufacturing, Design Assurance, Service team etc. on system behavior,... ...oscilloscope, etc. Familiarity with medical device software development or related domain...Medical deviceFull timeWork experience placement
- ...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
- ...improvements through partnership with Product Quality Engineering, Design Assurance, Regulatory Affairs, Corporate Quality, and other quality... ...discipline. Experience 8+ years of experience in medical device, healthcare, life sciences, or another regulated industry....Medical device
$55.06k - $68.84k
...have access to a comprehensive benefits package including: ~ Medical insurance – PPO, HMO & ~ Dental & Vision insurance ~401k plan... ...pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer...Medical device- ...Delaware. This Long-term Contract position is ideal for someone who is detail oriented and has experience in pharmaceutical or medical device communications, and who can contribute to educational campaigns, customer-facing programs, and event-driven marketing efforts in...Medical deviceLong term contract
- ...position is ideal for someone with experience in pharmaceutical or medical device marketing who can contribute to customer engagement,... ...Coordinate educational content initiatives, including materials designed for customer and learning audiences.• Contribute to planning...Medical deviceLong term contract
$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- ...Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural,...Medical deviceFor contractors
$25 - $30 per hour
...document results. Ensure that design, implementation, test, and... ...room. Benefits ~ Medical, Vision, and Dental Insurance... ...client is a leading medical device manufacturer operating across... ...manufacturing technicians, quality assurance professionals, receiving...Medical deviceContract workWork at officeWork visaShift workDay shift- ...understanding and action? Do you thrive at the intersection of medical rigor and bold design, where creative excellence directly influences how... ...emerging technologies that advance our capabilities.Quality Assurance and Compliance Readiness: Ensure all deliverables meet...Full timeLocal areaShift work
- ...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
$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
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