- 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
- Michael Page (Yonkers, NY)
- …up with a growing Medical Device Manufacturing Company in their search for a Quality Engineer to join the team due to growth. This position will report into the ... regulated industry. If interested, please read on and apply to the Quality Engineer - Medical Device Job based near Yonkers, NY. Job Description The Quality … more
- Michael Page (Westborough, MA)
- …BS degree in engineering or equivalent - Minimum 2 years' experience in a Quality Engineering role for a medical device manufacturer or equivalent - Familiarity ... Collaborative and Regulated Environment: Work within a team-oriented culture that emphasizes quality and compliance with stringent medical device regulations and… more
- Katalyst HealthCares and Life Sciences (Lake Bluff, IL)
- …Perform System Retirement of systems that are not in business. Understanding of Medical Device Quality and Compliance. Good knowledge of GxP, GAMP and 21CFR Part ... quality assurance or software validation, preferably within the medical device industry. Strong understanding of quality standards and regulatory… 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
- Eli Lilly and Company (Concord, NC)
- …to make life better for people around the world. Responsibilities: The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, ... and quality knowledge on a day to day basis. They...local process team for one of following manufacturing areas: Device Assembly Packaging Project Focus for DAP Responsibilities include:… 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
- 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
- Sanofi (Cambridge, MA)
- …coordination while collaborating closely with cross-functional teams and interacting with Global Device / Quality Leadership Teams and other senior leaders. You ... and their families. You serve as a crucial member of the Global Device Platform Engineering Team, taking responsibility for ensuring robust device design… more
- PTC (Boston, MA)
- …closely with the team to drive the strategy and roadmap for our Windchill Quality Management and Medical Device solutions, including key concepts such as ISO ... quality processes, FMEA and supplier quality collaboration processes. Critical to the role will be...as APQP, 8D, FRACAS and FMEA *Experience in medical device manufacturing and the ISO 13485 standard will be… more
- Mastech Digital (Danbury, CT)
- …implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive ... of GMP and GDP Principles Beneficial: - Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements - Knowledge of… more
- Actalent (Butler, WI)
- …products are manufactured following FDA regulations. Essential Skills Experience in quality control, particularly in medical device products. Proficiency in ... Job Title: Quality Technician Job Description We are seeking a...Work Environment The position is based in a medical device clean room environment, known for its high cleanliness… more
- Frida (Miami, FL)
- … device industry. Thorough knowledge of FDA regulations, ISO 13485, and medical device quality systems. Certified quality professional (CQE, CQA, or ... Make an Impact Frida is looking for a Supplier Quality Engineer to join our Operations team to take...in managing our critical supplier relationships and ensuring the quality and compliance of all our products. In this… more
- Michael Page (Genoa, WI)
- …developing their own employees professionally. Job Description Lead and manage the Quality Assurance (QA) Department Ensure product quality by developing, ... to new product development and enhance existing production processes Uphold company quality standards and ensure compliance with ISO 9001 and ISO 13485 audit… more
