- Merck & Co. (Rahway, NJ)
- …injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new ... types of engineering plus 10 years of related experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for...launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,… 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)
- …advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years ... role.Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly,… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... for CMC.- Strong understanding of integration and partnering with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areas.Demonstrated… more
- Repligen (Rancho Dominguez, CA)
- …Diploma, GED, or equivalent required.0 - 1 years of production/manufacturing with medical device assembly experience preferredWhat Repligen OffersOur mission is ... to SOP's.Comply with Good Documentation Practices on all Production and Quality Documents.Responsible for packaging products, assembly of kits, verifies form, fit,… more
- Repligen (Rancho Dominguez, CA)
- …fluency in English (reading and writing) is required.3+ years of medical device assembly experience.Experience working with hand tools, power ... member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion.ResponsibilitiesPerform manual assembly of… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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 ... team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale and team commitments to goals and objectives by… 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 ... subject area and the following amount of work experience in combination device or medical device industry for each level: + Associate Quality Engineer:… more
- Kelly Services (Springfield, MO)
- **Overview:** Our client is seeking a Contract Quality Engineer with medical device experience to support the successful implementation of ISO 13485 at our ... role is critical as they onboard a newly acquired medical customer and align their quality systems...and ISO expectations. **Required Experience:** + Proven experience in medical device manufacturing environments. + Hands-on implementation… more
- Kelly Services (Germantown, WI)
- …+ Process supplier and customer change notices. + Serve as manufacturing liaison for quality -related issues. + Approve medical device releases: + Conduct ... years of experience in a quality engineering role within the medical device manufacturing environment + Understanding of quality standards and regulatory… 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 ... + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. + Demonstrates knowledge of… more
- Lilly (Indianapolis, IN)
- …+ Demonstrated Project Management skills + Familiarity and practical experience with medical device / combination product quality & regulatory ... will provide leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination product commercialization… 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, ... Device Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management Systems (QMS). + 3+ years of technical program… more
- Caldera Medical (Westlake Village, CA)
- …engineering, Life Sciences, or a related technical field. - 10+ years of experience in medical device Quality , including leadership roles. * Minimum of 5 ... Quality Management System (QMS), ensuring alignment with global medical device regulations such as ISO 13485,...Medical is a growth stage medical device company dedicated to improving the quality … more
- Minnesota State (St. Cloud, MN)
- …a Master of Science Degree and a Graduate Certificate credential option. Graduate level Medical Device Quality (MTQ) course instruction. To learn more about ... Degree + Minimum of ten years of applicable industry experience in Medical Device Quality Systems, Risk Management, Quality Engineering, Design… more
