. Proven track record of driving lean and six sigma initiatives in a regulated environment. Led and managed development of DHF...
established hypotheses. Create appropriate project plan/documentation to adequately create a Design History File (DHF...
with quality management systems (QMS) and maintaining a design history file (DHF) is highly preferred. Strong problem-solving...
(DHF) of all projects within the guidelines of company procedures and practices. Oversee the development and maintenance...
complaint Design history Files (DHF) for each project Managing all aspects of assigned projects to ensure timely completion...
(DHF) to ensure compliance with regulatory standards and internal quality requirements. This role is essential for guiding... with regulatory standards. Ensure that all DHF documentation is up-to-date and reflects the current design and development status...
with the creation of project plans and Design history Files (DHF) for each project Partnering with engineers on all aspects...
for major & reference markets (US/Canada, EU, AUS) Provide strategic planning throughout the product lifecycle (DHF & change...
documentation of DHF’s, DMR’s, and DHR’s for each project in group according to Globus quality policy and all FDA...
organizations (CMOs). Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk...