- Merck & Co. (Rahway, NJ)
- …and injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for ... plus 10 years of related experienceHas 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
- Merck & Co. (Rahway, NJ)
- …in medical device engineering, particularly in the design , manufacturing, verification, validation and associated quality and regulatory aspects ... development activities including engineering design , engineering analysis and testing, medical device design controls, risk management, test method/… more
- Merck & Co. (Rahway, NJ)
- …product control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the ... have a background in data science, statistics, and a strong understanding of medical device and combination product regulations and processes.- It is expected… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … more
- Merck & Co. (Rahway, NJ)
- …with design of IV and SC drug products including drug- device combination products for biologicsExperience with process design and/or scale-up ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... safety, efficacy, and delivery. -During development, we leverage smart experimental design , cutting edge analytical tools, and predictive approaches to inform… more
- Twist BioScience (South San Francisco, CA)
- …Sciences or Engineering.8+ years of experience managing projects in biotech, medical device or pharmaceutical industry, with prior technical ... timeline, meeting minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years of proven ... studies, prototype development, and advocate for scalable, compliant architecture and design .Collaborate with global quality , IT, and business leaders to… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance ... + Reviewing technical reports as well as documents for Design History Files + Participating in device ...in combination device or medical device industry for each level: + Associate Quality… more
- Pfizer (Kalamazoo, MI)
- …13485:2016 requirements and related standards. + Experience working in Medical Device or Combination Products Quality , Design Controls, Production, or ... patients. **ROLE SUMMARY** Responsible for implementation of Kalamazoo site Quality Systems for Medical Device /Combination...change requests for potential impact to device design and/or DHF document impact. + Supports medical… more
- Stryker (San Jose, CA)
- …to manage a team of Design Quality engineers that work on Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) for our ... you will do:** + Manage and develop a team of design quality engineers supporting Software as a Medical Device (SaMD) and Software in a Medical … 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
- 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
- Wolters Kluwer (Chicago, IL)
- …a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.… more
- AbbVie (Pleasanton, CA)
- …have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year of ... (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + working… more
- Kelly Services (Germantown, WI)
- …+ Process supplier and customer change notices. + Serve as manufacturing liaison for quality -related issues. + Approve medical device releases: + Conduct ... Contribute to product development and realization: + Participate in design reviews, process planning, and risk analysis. + Review...in a quality engineering role within the medical device manufacturing environment + Understanding of… more
- Lilly (Indianapolis, IN)
- …for people around the world. The Associate Director- Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible ... for quality control oversight of the Device Quality Laboratory. **Responsibilities:** + Provide leadership...820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL) + Regulatory inspection… more
- Merck (Rahway, NJ)
- …in medical device engineering, particularly in the design , manufacturing, verification, validation and associated quality and regulatory aspects ... development activities including engineering design , engineering analysis and testing, medical device design controls, risk management, test method/… more
- Zimmer Biomet (Englewood, CO)
- …in Engineering or technical discipline and 3 years of related experience + Medical device experience preferred + Process Validation experience preferred + ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's...+ Maintain an effective and complaint Calibration program + Design , validate and maintain quality management system… 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
