- Cytiva (Miami, FL)
- …in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer ( Design & Manufacturing) is responsible for… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …required.BS+7 or MS+4 years' experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), ... Engineer or Scientist is responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Science… more
- Cytiva (Miami, FL)
- …manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment. ... engineering or project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this ... Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located in Chaska, MN and will be on-site.… more
- Amgen (Cambridge, MA)
- …and transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** ... + Provide direction and support for all technical documentation ( Device Design /Testing, Design Outputs, Manufacturing...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Merck (Rahway, NJ)
- …injection._ **Job description** This position will be responsible for leading and implementing medical device and combination product design controls for ... years of related experience + Has broad knowledge of medical device development, design controls... and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971,… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …Engineering, or related field (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep understanding of FDA ... a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead and support design… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... IL and report directly into the Senior Manager of Medical Device Quality . + Leads...as the Quality reviewer and approver of device software design control tasks or IT… more
- Organon & Co. (Jersey City, NJ)
- …onsite within Organon's Jersey City office.** **Responsibilities** + Provide guidance on medical device design controls requirements to product development ... and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer (… 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 ... Certifications: ASQ CQE preferred + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. +… more
