ASP Global · 1 month ago
Principal Quality Engineer
Austell, GA
Full-time
Onsite
Lead/StaffASP Global is seeking a highly experienced and collaborative Principal Quality Engineer to join their Quality team. This role will lead risk management activities and support new product introductions for Class I and II medical devices marketed in the US.
Medical
Responsibilities
Own the creation, maintenance, and continuous improvement of Risk Management Files in accordance with ISO 14971
Facilitate cross-functional risk assessments throughout the product lifecycle
Partner with R&D to ensure quality is built into the design and development of new products
Provide quality engineering support for design changes, product updates, supplier diversification, and post-market surveillance
Provide process and test method validation expertise to suppliers and internal teams
Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements
Support internal and external audits
Lead or support internal investigations, including CAPA and nonconformances
Mentor and provide technical guidance across teams
Foster a culture of quality, continuous improvement, and cross-functional collaboration
Qualification
Required
Deep expertise in ISO 13485
Deep expertise in ISO 14971
Deep expertise in design control
Deep expertise in validations
Deep expertise in quality systems
Preferred
Experience in EU MDR technical documentation
Company
ASP Global
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim.
Founded in 2003
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Incline Equity Partners
2024-08-06Acquired
2020-02-11Private Equity
Leadership Team
Doug Shaver
Chief Executive Officer
Justin Martin
Chief Product Officer & General Manager, Injury Prevention
Recent News
2023-06-13
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