- Merck & Co. (Rahway, NJ)
- … medical devices and combination products globally.- Experience in design controls, device risk management, medical device , complex combination product ... are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product needs for commercial products-… more
- Novo Nordisk Inc. (Durham, NC)
- …years of validation related discipline experience in pharmaceutical or medical device industry required Experience in quality concepts including technical & ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...life-changing careers, and the opportunity to help improve the quality of life for millions of people around the… 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
- Aequor (Thousand Oaks, CA)
- … quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation according to company ... guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement… more
- Aequor (Thousand Oaks, CA)
- …improvements for ICSR medical review Conduct reportability assessment for medical device associated events and/or product complaint associated events, and ... of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and lead activities for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equivalent experience from any of these industries: Pharmaceuticals, biologics, Medical Device , Vaccines, Diagnostics, Generics/ Consumer productsDemonstrated ... around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, ... advanced analytical tools and assays. Clinical data management experience in a medical device , pharmaceutical company, or similar environment (eg, CRO);… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Repligen (Rancho Dominguez, CA)
- …by Management.QualificationsHigh School Diploma, GED, or equivalent required.3+ years of medical device assembly experience. Experience working with hand tools, ... 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)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake County,… more
- Astrix Technology (Fort Worth, TX)
- ** Quality Assurance Manager - Medical Device ** Quality Assurance Fort Worth, TX, US Pay Rate Low: 85000 | Pay Rate High: 90000 + Added - 04/06/2025 Apply ... looking for a sharp professional that possesses these top 3 skills:** + Medical Device /Pharmaceutical industry experience + 4+ Years of Quality Assurance and… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... Organon's Jersey City office.** **Responsibilities** + Provide guidance on medical device design controls requirements to product...cGMP and quality issues related to pure medical devices and the device constituent of… more
- Eurofins (Lancaster, PA)
- …review/write QAU procedures. The ideal candidate would possess : + Familiarity with GMP and Medical Device Quality System (21 CFR Part 820 and ISO 13485) ... to ensure that Eurofins, as an organization, is providing quality data in a timely manner that meets the...(if possessing no degree) + Experience in regulated industries ( Medical Device , Pharmaceuticals,) + Authorization to work… more
- Pentax Medical (Montvale, NJ)
- …in effective communication with cross functional teams for better alignment Requirements of Medical Device , Senior Quality Engineer: + Bachelor's Degree or ... Manager, Production/Manufacturing Why JOIN Us? We are an established medical device leader that is preparing for...employee engagement + Exceptional attention to service, detail, and quality + Familiarity with PENTAX Medical products… 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
