KH
Design Quality Lead
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Staff / Principal
5 months ago
- Risk Management
5 months ago
Not enough detail in this posting to match
Roles & Responsibilities:
- Serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of the project.
- Assures proper integration and support of device regulations, drug regulations, and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
- Ensures design control documentation (Traceability/Linkages) & design change control requirements are met. Assesses the impact of a change on the safety, efficacy of the combination product/device. Analyzes and justifies the impact on cumulative changes.
- 5+ years of total combined experience. At least 3 years in Device Design Quality Assurance
- What are the top 3-5 skills requirements should this person have?
- Deep understanding of DHF structure and traceability between DHF elements.
- Knowledge and a comprehensive understanding of combination products, medical devices, and design controls.
- Sound technical understanding of product development (e.g., approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
- Well-versed in risk management methodologies and their application.
- Ability to work independently and in a global team environment, and with all levels of personnel within the organization.
Design Quality Lead · Katalyst Healthcares & Life Sciences