Senior Quality Engineer

ASP Global; Austell (GA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

ASP Global in Austell, GA is seeking a Senior Quality Engineer to lead risk management, support new product introductions (NPIs), and sustain engineering for Class I and II medical devices marketed in the US.

You will implement ISO 14971 and ISO 13485, align with FDA QSR, partner with R&D, and mentor cross-functional teams to drive quality improvements across programs.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related technical discipline.
• 5+ years in quality engineering, product development, or manufacturing in medical devices.
• Experience with ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

Responsabilités

• Own risk management files per ISO 14971 and maintain them throughout the lifecycle.
• Facilitate cross-functional risk assessments across programs.
• Partner with R&D to embed quality in design and development of new products.
• Provide QA support for design changes, supplier initiatives, and post-market surveillance.
• Lead or support CAPA investigations and nonconformances.
• Mentor teams and promote a culture of quality and continuous improvement.

Connaissances

Risk management

Design control

Quality systems

CAPA

Cross-functional collaboration

Mentoring

Statistical methods

Problem solving

Formation

Bachelor’s degree in engineering or life sciences

Master’s degree or ASQ CQE/CQA (preferred)

Description du poste

Position SummaryWe are seeking a highly experienced and collaborative Senior 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 experience 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.• 5+ years of experience in quality engineering, product development, or manufacturing with the medical device industry.• Demonstrated experience with leading 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.