Principal Quality Engineer at ASP Global, LLC

Austell, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Feb, 26

Salary

0.0

Posted On

24 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Risk Management, Design Control, ISO 13485, ISO 14971, FDA QSR, Statistical Methods, Product Development, Manufacturing, CAPA, Nonconformances, Mentoring, Cross-Functional Collaboration, Process Validation, Test Method Validation, Post-Market Surveillance

Industry

Description

Job Details Job Location: AUSTELL, GA Position Type: Full Time Education Level: 4 Year Degree Salary Range: Undisclosed Travel Percentage: None Job Category: QA - Quality Control Position Summary We are seeking a highly experienced and collaborative Principal Quality Engineer to join our Quality team. This role will be instrumental in leading risk management activities, supporting new product introductions (NPIs), and sustaining engineering efforts for primarily Class I and II medical devices marketed in the US. The ideal candidate will bring deep expertise in ISO 13485, ISO 14971, design control, validations, and quality systems, with a strong preference for experience in EU MDR technical documentation. Key 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. Minimum Qualifications Bachelor’s degree in engineering, life sciences, or related technical discipline. 8+ years of experience in quality engineering, product development, or manufacturing with the medical device industry. Demonstrated expertise in risk management and design control activities. Solid understanding of statistical methods used in capability analysis, trend analysis, sampling plans, and data interpretation. Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820. Familiarity with Class I medical devices and U.S. market requirements Proven ability to mentor cross-functional teams and drive quality initiatives. Excellent communication, problem-solving, and organizational skills. Preferred Qualifications Master’s degree or advanced certification (e.g., ASQ CQE, CQA). Experience with EU MDR technical documentation and regulatory submissions.

Responsibilities

The Principal Quality Engineer will lead risk management activities and support new product introductions for Class I and II medical devices. This role involves ensuring compliance with quality standards and fostering a culture of continuous improvement.