- Penn Medicine (Philadelphia, PA)
- …leadership and direction in regards to all administrative, financial, regulatory , quality , human resources, patient/employee satisfaction, and clinical ... all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW,… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …+ Build and leverage strong relationships across departments (R&D, Supply Chain, Quality , Regulatory , Support Services) to align goals and drive decisions. ... builds, ramp-up activities, and production scaling while ensuring compliance with regulatory and quality standards (including post-market surveillance support) .… more
- Medtronic (Juncos, PR)
- …validation protocols to ensure equipment, systems, and processes meet regulatory , quality , and performance requirements under FDA , ISO 13485, and GxP ... digital factory technologies. + Ensure validation packages comply with FDA 21 CFR Part 11, ISO 13485, EU MDR,...ensure validation alignment with digital systems. + Partner with Quality and Regulatory Affairs to ensure validation… more
- J&J Family of Companies (Santa Clara, CA)
- …validate, and implement various processes by working closely with R\&D, Operations, Regulatory , and Quality teams to support the company's manufacturing ... invention disclosures and patent applications. + Supports company goals, policies, procedures, quality \sSystems, and FDA regulations. + Perform other duties as… more
- Terumo Medical Corporation (Elkton, MD)
- …qualification of products, processes, and control systems in compliance with TMC Quality System requirements and regulatory standards. b. Provide strategic ... delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA . 3. Problem-Solving Skills: a.… more
- Lilly (Concord, NC)
- …effectively with a cross functional group. + Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + ... by example and provide coaching to others in the areas of safety, quality , operational excellence, compliance, and continuous improvement. The AD will be responsible… more
- Billings Clinic (Billings, MT)
- You'll want to join Billings Clinic for our outstanding quality of care, exciting environment, interesting cases from a vast geography, advanced technology and ... regional locations) and how we are recognized nationally for our exceptional quality . Your Benefits We provide a comprehensive and competitive benefits package to… more
- Bristol Myers Squibb (Devens, MA)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, ... and external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Lilly (Indianapolis, IN)
- …and ensure alignment to business goals. Develop team goals for safety, quality , and process effectiveness and efficiency. + ** Regulatory Compliance:** Ensure ... + Experience in device assembly and/or packaging. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Safety… more
- DEKA Research & Development (Manchester, NH)
- …Practices; meets QMS requirements; and complies with US Food and Drug Administration ( FDA ) regulations / other regulatory requirements. + Identify and make sound ... handling investigations, medical device reporting, or product analysis. + Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical… more
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Quality Engineer Intern (Req #: 1260)
- Peckham Industries (Shaftsbury, VT)