- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, ... and commercializes novel biologic/ drug/ vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The… more
- Merck & Co. (Rahway, NJ)
- …- Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and ... commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD&T… more
- Merck & Co. (Rahway, NJ)
- … device and combination product regulations, manufacturing processes, and quality control.Proficiency in advanced statistical methods, such as partial least ... strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical company. The… more
- Merck & Co. (Rahway, NJ)
- …Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Durham, NC)
- …with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …(PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... drug/delivery device supply strategies-Building our leadership and functional capability to...Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired… more
- Aequor (Hicksville, OH)
- …to designated area by manual or power floor jack, dolly or other device . Assemble shippers, removes trash, product waste from packaging area. Cleans and sanitizes ... to service multiple packaging lines simultaneously. Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems… more
- Twist BioScience (South San Francisco, CA)
- …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 ... Engineering.8+ years of experience managing projects in biotech, medical device or pharmaceutical industry, with prior technical experience.Self-motivated, ambitious… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global… more
- Repligen (Rancho Dominguez, CA)
- …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 ... routing table, washing machine, annealing auto clave, tweezers, picks. Identifies quality problems and follows reporting procedures.Ability to read and follow work… 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)
- …to SOP's.Comply with Good Documentation Practices on all Production and Quality Documents.Responsible for packaging products, assembly of kits, verifies form, fit, ... or equivalent required.0 - 1 years of production/manufacturing with medical device assembly experience preferredWhat Repligen OffersOur mission is to inspire… 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 of IDM Device Quality Control Lab +… more
- Amazon (Monroe, OH)
- Description The Device Quality Manager (DQM) is responsible for ensuring that Amazon products are produced and packaged to meet or exceed our high bar for ... and an excellent customer experience. The DQM is responsible for the device quality during development of each project, during the production (sustaining) phase,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Device Quality Engineering Lead **Location** : Cambridge, MA **About the Job** At Sanofi, we're committed to providing the next-gen ... with external LMR partnerships. Join our Global Digital Team as a Digital Device Quality Engineering Lead. You will be responsible for the quality assurance… 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 in ... device risk management activities + You have a quality mind-set To be considered for this role you...work experience in combination device or medical device industry for each level: + Associate Quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant Quality ... Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or...in a Quality Assurance role for medical device or pharmaceutical manufacturing. + Demonstrates knowledge of statistical… 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 ... they onboard a newly acquired medical customer and align their quality systems with regulatory and customer-specific requirements. **Key Responsibilities:** + Lead… more
- Lilly (Durham, NC)
- … products, through effective execution of product testing **Position Description:** The Sr. Manager, Quality Control (QC) - Chemistry and Device leads a team of ... an exciting opportunity to help a state-of-the-art facility and Quality System. The Quality Control Laboratory assures...laboratory personnel supporting routine and non-routine device , water, and drug product testing. The Sr. Manager… more
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