- Brady Corporation (Milwaukee, WI)
- …(SOPs), Quality Manual, Quality Policies, and related procedures, ensuring compliance with applicable medical device regulations. + Support New ... 3-5 years of experience in regulatory affairs, compliance , or quality in the medical device industry. + Experience working with cross-functional teams,… more
- Vera Therapeutics (Brisbane, CA)
- …with senior management to provide updates on the status of quality and compliance for medical device / combination product * Participate in preparation ... and effective for patient use. Responsibilities: * Oversee the quality and compliance of combination product, ensuring...quality operations * Stay up-to-date with changes in medical device and combination product regulations and… more
- Abbott (Caguas, PR)
- …+ BS in engineering discipline + 0-1 years of experience in Quality and/or Compliance , preferably in medical device industry + Knowledge of applicable US ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Barceloneta, PR)
- …in engineering discipline + 2 years of experience in Quality and/or Compliance , preferably in medical device industry **Preferred Qualifications** + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Organon & Co. (Jersey City, NJ)
- …of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( Medical ... Participate on Organon teams supporting cGMP and quality issues related to pure medical devices and the device constituent of a combination product. + Work… 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 ... External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Quality compliance support for the following Quality tasks...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... Compliance of SaMD Products:** + Represent Digital Device Quality Engineering on cross-functional teams and...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Takeda Pharmaceuticals (Boston, MA)
- …in Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality , PV Compliance etc. **ACCOUNTABILITIES:** + Ensure ... organizational compliance with relevant medical device legislations and regulations + Prepare,...engagements with both internal and external stakeholders, including the Medical Safety, Device Quality Assurance,… more
- Merck (Rahway, NJ)
- …The primary role for this position is to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls IT solution JANUS with ... transactional data. With direction and guidance from the Director Quality Systems & Compliance , this role is...5+ years of experience within the pharmaceutical, biotechnology, or medical device industries with at least 3… more
- Amgen (Cambridge, MA)
- …transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** Let's ... between risk (Use and Functional) and Requirements + Ensure compliance /closure of Regulatory and Quality requirements before...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. The Quality Assurance Associate - Device Assembly & Packaging team provides daily oversight, ... - Quality Assurance position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various… more
- Merck (West Point, PA)
- …medical devices and combination products globally. Experience in design controls, device risk management, medical device , combination products, ... our Company divisional and local site procedures for safety, quality , and regulatory compliance + Understand the...of decisions and expectations + Lead technical investigations of medical device and combination product needs for… more
- Takeda Pharmaceuticals (Boston, MA)
- …alignment for other medium and/or high complexity products (including combination, Software as a Medical Device , and standalone medical device products). ... labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory… more
- Lilly (Indianapolis, IN)
- …with DOE's, GR&R's or process capability studies. + Previous drug delivery, medical device or pharmaceutical industry experience. + Experience working with ... in Lilly's portfolio. The QA Representative - Commissioning and Qualification provides quality oversight and support for medical devices and combination products… more
- IQVIA (Detroit, MI)
- …Sales Consultants_** to join our team of field employee's. **Associate Sales Consultant - Medical Device ** If you have ever wondered about the intricacies of ... surgical procedures or considered a career path in medical device sales, this is the role...presentable manner. Ensure client's services and offering meet highest quality standards + Know and follow all laws and… more
- Merck (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on ... development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture… more
- Sanofi Group (Morristown, NJ)
- …with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and...standards and guidelines. The incumbent has a patient- and quality -focused mindset and drives a culture of continuous improvement… more
- Merck (Rahway, NJ)
- …**Job description** This position will be responsible for leading and implementing medical device and combination product design controls for both new ... with external suppliers. + Understand and apply regulatory / compliance requirements relative to design controls and risk management...years of related experience + Has broad knowledge of medical device development, design controls and risk… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world._ Organization Overview: The Indianapolis Device Assembly & Packaging (IDAP) quality assurance flow mentor provides ... technical leadership and expertise for quality production support in the following areas: coaching and...cause analysis and countermeasure development and implementation for major compliance or throughput event investigations. + Perform reviews of… more
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