Principal Quality Engineer

NAMSA; Atlanta (GA); On-site; USD 80,000 - 120,000; Full time

Job summary

NAMSA, a leader in medical device development, seeks an experienced engineer to champion quality and compliance processes. The role involves overseeing validation activities, documenting processes, and mentoring teams in a dynamic work environment. Ideal candidates will have strong technical backgrounds and project management skills.

Qualifications

• At least 8-10 years of engineering experience required.
• Expertise in applying regulatory requirements to system qualifications.
• Technical expertise in Building Automation Systems.

Responsibilities

• Design, execute, and analyze non-routine qualifications and process validations.
• Collaborate on GxP documentation and compliance.
• Mentor and guide engineering associates.

Skills

Communication

Project Management

Critical Thinking

Organization

Time Management

Education

Bachelor’s degree in engineering or related scientific discipline

M.S. preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Job description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision: to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success.

Mission: to deliver best-in-class global MedTech development solutions through our people, expertise, and technology by adhering to our core values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives, and ideas.

Job Description:

1. Champion initiatives for identifying and developing criteria for procurement and installation of new Measurement and Test Equipment (M&TE) for laboratories, respecting testing standards.
2. Design, write, and execute non-routine qualifications, requalifications, process validations, and building validations for M&TE as required by industry regulations (e.g., 21 CFR Part 820, ISO 17025).
3. Analyze qualification, requalification, and validation raw data and generate final reports.
4. Collaborate with CSV and IT to complete GxP documentation, compliance, and validation of equipment generating electronic data compliant with regulations (e.g., 21 CFR Part 11).
5. Investigate and troubleshoot using advanced mathematical and engineering knowledge.
6. Write and implement quality records such as change control plans, risk assessments, nonconformance, corrective, and preventive actions.
7. Apply technical expertise for requalifying, conducting process validations, and troubleshooting sterilizers and resistometers.
8. Drive purchasing processes for materials and services needed for owned departments.
9. Maintain and support equipment documentation in the Equipment Management System.
10. Provide training to associates on equipment use and processes.
11. Proactively address trending and analysis of TE failures.
12. Install, validate, troubleshoot, and maintain continual monitoring points.
13. Assist laboratory personnel with continuous monitoring and alarm investigations.
14. Perform periodic reviews of engineering software systems.
15. Assist management with department metrics, data gathering, and supporting capital projects.
16. Provide equipment records for client audits and qualification/validation SME support.
17. Mentor teammates, prioritize tasks, and guide the team in alignment with engineering management.
18. Apply engineering techniques for proactive equipment planning.
19. Ensure proper archiving and disposal of equipment files.
20. Interface with internal groups on equipment and quality issues.
21. Update procedures and training related to engineering processes.
22. Support harmonization of equipment and documentation across NAMSA sites for global alignment.
23. Assist with internal/external document review for industry regulation updates.

Qualifications & Technical Competencies:

• Bachelor’s degree in engineering or related scientific discipline required; M.S. preferred.
• 8-10 years of engineering experience.
• Proficiency in Microsoft Word, Excel, and Project.
• Expertise in applying regulatory requirements to system qualifications, validations, and reports.
• Technical expertise in Building Automation Systems.
• Strong communication, organization, and time management skills.
• Ability to work independently and as part of a team, mentoring engineering associates.
• Critical thinking skills for designing and completing validation processes for engineering software systems.
• Strong project management skills ensuring timely, within-budget completion, and coordination with departments and vendors.

Working Conditions:

Employees must meet physical demands necessary to perform essential functions, with reasonable accommodations provided for disabilities. The role involves talking, hearing, standing, walking, sitting, handling, reaching, climbing, and balancing. Employees must frequently lift/move up to 50 pounds. Vision requirements include close, distance, color, peripheral, depth perception, and focus adjustment.