- Michael Page (Hudson, NH)
- …The Successful Applicant Technical & Standards Savvy - Solid familiarity with medical- device quality and risk-management standards (ISO 13485, ISO 14971, ISO ... Dive into projects with moderate to high complexity-leading compliance reviews, interpreting quality and regulatory demands, and ensuring we always align with the… more
- Diverse Lynx (Irvine, CA)
- …Title: Engineer Location: Irvine, CA Duration: Contract Job Description : Mechanical Engineer, Quality , Medical Device Competencies: EIS : Medical Device & ... Regulations Experience (Years): 0-2 Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their… 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)
- 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
- Synergy America, Inc. (Maumelle, AR)
- …Currently reviewing and shortlisting resumes. Initial feedback is that several candidates are at management level. This position is not management and involves being ... the individual to write and execute protocols. Thank you. 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
- Terumo BCT, Inc. (Littleton, CO)
- …investigations, this position is ideal for professionals with experience in medical device quality systems. If you're passionate about improving lives through ... we go next. You create your future and ours. As a Senior Quality Specialist (Complaint Investigation), where your expertise will directly impact patient safety and… 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
- 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
- Ortho Clinical Diagnostics (Rochester, NY)
- …for all. The Role As the company continues to grow, we are seeking a Quality Technician III for Device History Record (DHR) review and Incoming Inspection. This ... acceptance. Inspects raw materials for compliance against specifications. Reviews Device History Records (DHRs) and Incoming Inspection documentation for accuracy,… more
- Merz North America (Raleigh, NC)
- …support of Project Teams and R&D overall to assure global compliance. Including: Quality activities for medical device manufacturing and Design & Development ... in Engineering or Life/Health Sciences 7 - 8 years of relevant Quality medical device development experience 4 year of people management experience Energy-Based … 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
- 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
- Boston Scientific (St. Paul, MN)
- …Bachelor's degree in electrical engineering. Preferred Qualifications: Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO ... 13485 Quality Standards Experience in Medical Device industry or a Quality organization Proficient with Microsoft Office tools including Word, Excel,… more
- Actalent (Butler, WI)
- …products are manufactured following FDA regulations. Essential Skills: Experience in quality control, particularly in medical device products. Proficiency in ... Quality Technician We are seeking a Quality...Work Environment: The position is based in a medical device clean room environment, known for its high cleanliness… more
