5+ years of total combined experience, with 3+ years in Device Design Quality Assurance.
Deep understanding of Device History File (DHF) structure and traceability between its elements.
Knowledge of combination products, medical devices, and design controls.
Technical expertise in product development, particularly in requirements definition and verification.
Familiarity with risk management methodologies and their practical application.
Ability to work independently and collaboratively within a global team.
Responsibilities
Lead quality initiatives to ensure timely delivery of high-quality project outcomes.
Ensure compliance with device and drug regulations and internal company policies.
Oversee design control documentation and assess changes for their impact on safety and efficacy.
Analyze the implications of cumulative changes on design control requirements.
Drive all quality and compliance activities related to project deliverables.
Benefits
Opportunity to lead critical quality initiatives in an innovative environment.
Exposure to a diverse range of projects involving combination products and medical devices.
Collaboration with global teams and personnel at all levels of the organization.
Full 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.
Education & Experience:
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.
