- 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 ... product launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, verification,… 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 ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… 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 ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … 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
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… 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)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and… more
- Lilly (Indianapolis, IN)
- …and practical experience with medical device / combination product quality & regulatory requirements, including GMP/CFR, EU MDR, ISO and IEC requirements ... will provide leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination product commercialization… more
- Stryker (Redmond, WA)
- …Medical Device . + A minimum of 4 years of Medical Device Quality or Regulatory Affairs experience required. **Preferred** + Supervisory experience ... ISO, FDA, and international requirements required + Demonstrated technical knowledge of medical device product line required + $132,900.00 - 217,500.00… more
- Edwards Lifesciences (Irvine, CA)
- …role will provide high- quality guidance and support to Edwards' leaders on medical device commercial, clinical, regulatory , quality and reimbursement ... legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this... guidance and support to Edwards' on healthcare and medical device regulatory matters, including… more
- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
- West Pharmaceutical Services (Walker, MI)
- …engineering **Work Experience** + Minimum 10+ years in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, or a ... execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination...regulatory requirements such as 21CFR Part 820 for Medical Devices and 21CFR Part 210, 211 & Part… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… 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 ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Wolters Kluwer (Chicago, IL)
- …the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA ... a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important… 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 ... and quality standards, providing metrics, and addressing quality and regulatory issues. + Author and...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance, and quality assurance ... Assurance** + Ensure all Globus products and processes meet regulatory and internal quality standards. + Review,...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- Kelly Services (Springfield, MO)
- **Overview:** Our client is seeking a Contract Quality Engineer with medical device experience to support the successful implementation of ISO 13485 at our ... onboard a newly acquired medical customer and align their quality systems with regulatory and customer-specific requirements. **Key Responsibilities:** +… more
