- Cytiva (Miami, FL)
- …in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer ( Design & Manufacturing) is responsible for… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …required.BS+7 or MS+4 years' experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), ... Engineer or Scientist is responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Science… more
- Raytheon (Tucson, AZ)
- …complex systems. Our precision software and firmware integrate operating systems, device drivers, networking, and control software to bring together sensor, ... all aspects of the software development lifecycle. Our 4000+ software engineers design , develop, and build innovative solutions for our customers. Join our… more
- Cytiva (Miami, FL)
- …manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment. ... engineering or project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this ... Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located in Chaska, MN and will be on-site.… more
- Kelly Services (Santa Clara, CA)
- … Quality Engineer_** _for a long-term contract at one of our_ **_Global Medical Device Robotics & Digital Solutions_** _clients in_ **_Santa Clara, CA_** _. ... system quality engineering team._ _Medical Device_ **_Design Quality Engineer_** _on-site_ **_Responsibilities_** _: Support_ **_design verification/ design … more
- Amgen (Cambridge, MA)
- …and transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** ... + Provide direction and support for all technical documentation ( Device Design /Testing, Design Outputs, Manufacturing...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Merck (Rahway, NJ)
- …injection._ **Job description** This position will be responsible for leading and implementing medical device and combination product design controls for ... years of related experience + Has broad knowledge of medical device development, design controls... and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971,… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …Engineering, or related field (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep understanding of FDA ... a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead and support design… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... IL and report directly into the Senior Manager of Medical Device Quality . + Leads...as the Quality reviewer and approver of device software design control tasks or IT… more
- Organon & Co. (Jersey City, NJ)
- …onsite within Organon's Jersey City office.** **Responsibilities** + Provide guidance on medical device design controls requirements to product development ... and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer (… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Certifications: ASQ CQE preferred + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. +… 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 of ... vision and team to support our clients in the medical device industry across their product innovation,... industry across their product innovation, regulatory compliance, and quality assurance processes. This role will focus on establishing… more
- US Tech Solutions (San Bruno, CA)
- …and align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design /Process ... to release, manage project schedules, mitigate risks, handle the Design History File, and align with stakeholders. + Collaborate... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Lilly (Indianapolis, IN)
- …with DOE's, GR&R's or process capability studies. + Previous drug delivery, medical device or pharmaceutical industry experience. + Experience working with ... portfolio. The QA Representative - Commissioning and Qualification provides quality oversight and support for medical devices...development engineering on device design / assembly requirements interface (DFM/DFA)… more
- Lilly (Indianapolis, IN)
- …Director will provide management oversight for quality system activities performed by Quality Assurance in the medical device complaint handling area. To ... and maintenance of the complaint handling elements of the quality system for devices and drug/ device combination...with use, design , and manufacturing investigations for medical devices and drug/ device combination products +… more
- Amazon (Sunnyvale, CA)
- … quality of new products and SW releases. Key job responsibilities * Design and execute comprehensive quality strategies that align with the organization's ... device makers. Basic Qualifications - 6+ years of quality assurance engineering experience - 4+ years of delivering...compensation package, in addition to a full range of medical , financial, and/or other benefits. For more information, please… more
- Sanofi Group (Cambridge, MA)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... You will be responsible for concept development of innovative medical device technologies, from ideation to proof... development of complex technical products + Expert in device design from innovation to late-stage development… more
- Sanofi Group (Morristown, NJ)
- …with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and...standards and guidelines. The incumbent has a patient- and quality -focused mindset and drives a culture of continuous improvement… more
- Sanofi Group (Cambridge, MA)
- …and sustainable medical device regulatory strategies covering diagnostic ( device elements); + Prepare regulatory design control deliverables; + Review ... with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product… more
