Quality Engineer

Insight Global; Atlanta (GA); Hybrid; USD 120,000 - 125,000; Full time

Job summary

Insight Global is seeking a highly experienced Senior Quality Engineer to lead risk management activities for medical devices in the US. You will work on ISO 14971, ISO 13485, design controls, validations, and support NPIs and sustaining engineering.

You will drive CAPA, audits, post-market surveillance, and mentor cross-functional teams while aligning with FDA QSR requirements. Hybrid role in Austell/Atlanta, with compensation of $120k–$125k plus 10% bonus.

Qualifications

• Experience with risk management and design control activities.
• Bachelor’s degree in engineering, life sciences, or related field.
• 5+ years in quality engineering for medical devices.

Responsibilities

• Own the creation, maintenance, and continuous improvement of Risk Management Files per ISO 14971.
• Facilitate cross-functional risk assessments throughout the product lifecycle.
• Partner with R&D to ensure quality in 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 systems.
• 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 and cross-functional collaboration.

Skills

Risk management

Quality engineering

Cross-functional collaboration

Mentoring

Problem-solving

Communication skills

Education

Bachelor's degree in engineering or life sciences

Master's degree

Tools

CAPA system

Design controls

ISO 13485

ISO 14971

FDA QSR

Regulatory submissions

Job description

Location: Austell, GA - Hybrid (In-office Tuesday & Wednesday). Moving to Atlanta, GA later this year.

Salary Target: $120,000-$125,000 + 10% bonus. Exact compensation may vary based on several factors, including skills, experience, and education.

We 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.

Qualifications

• Experience with product development from inputs through verifications


• 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.

Compensation:

$120,000 to $125,000 per year annual salary. Exact compensation may vary based on several factors, including skills, experience, and education.