Design Quality Lead
Karwell TechnologiesNorth Chicago, IL
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Overview
Remote
On-site
Job Description
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.
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FAQs About Design Quality Lead Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in North Chicago, IL, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
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