- 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
- Katalyst HealthCares and Life Sciences (Lake Bluff, IL)
- …systems. Perform System Retirement of systems that are not in business. Understanding of Medical Device Quality and Compliance. Good knowledge of GxP, GAMP ... maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO… 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
- Michael Page (Yonkers, NY)
- …experience in a highly regulated industry. If interested, please read on and apply to the Quality Engineer - Medical Device Job based near Yonkers, NY. Job ... Description The Quality Engineer - Medical Device Manufacturing will be responsible for the following: Develop, implement, and maintain quality processes… 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
- 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
- Mastech Digital (Danbury, CT)
- …Develops and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical ... - Knowledge of GMP and GDP Principles Beneficial: - Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements… more
- Michael Page (Westborough, MA)
- …- Minimum 2 years' experience in a Quality Engineering role for a medical device manufacturer or equivalent - Familiarity with ISO 13485 standards and 21 ... team-oriented culture that emphasizes quality and compliance with stringent medical device regulations and industry standards. Comprehensive salary and… 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
- Frida (Miami, FL)
- … device industry. Thorough knowledge of FDA regulations, ISO 13485, and medical device quality systems. Certified quality professional (CQE, ... Make an Impact Frida is looking for a Supplier Quality Engineer to join our Operations team to take...Love Working at Frida Robust health benefits including: Comprehensive medical , vision, and dental plans Employer paid life insurance… more
- Coloplast (Minneapolis, MN)
- …development, regulatory approval, production and launch. In depth knowledge within the medical device industry including quality requirements and regulatory ... overall related leadership experience. Previous management experience, preferably in the medical device industry. Demonstrated ability to manage multiple… more
- Terumo BCT, Inc. (Littleton, CO)
- …capabilities that enhance execution excellence across the organization. Ensure adherence to medical device regulations and quality standards throughout the ... JOB SUMMARY The Senior Program Manager orchestrates the execution of complex medical device development programs, through expert coordination of timelines,… more
- Katalyst HealthCares and Life Sciences (Pittsburgh, PA)
- … Quality , or a related field (master's preferred). 5+ years of experience in medical device quality engineering or a related field. Strong knowledge of ... Responsibilities: Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure … more
- IntePros (Audubon, PA)
- …is currently looking for a Director of Quality to join one of our growing Medical Device clients in Audubon, PA. The Director of Quality will Provide ... with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system requirements. The Director of Quality Responsible for… more
