Principal Quality Engineer

NAMSA in; Atlanta (GA); On-site; USD 100,000 - 130,000; Full time

Job summary

NAMSA, a pioneer in medical device testing, seeks a Principal Quality Engineer to lead quality initiatives and improve processes for Measurement and Test Equipment. This role involves designing qualifications, collaborating with technical teams, and ensuring compliance with industry regulations. Candidates should possess extensive engineering experience and strong project management skills.

Qualifications

• 8-10 years of engineering experience.
• Proficiency in regulatory requirements for system qualifications and validations.
• Ability to work independently and mentor others.

Responsibilities

• Lead initiatives for procurement and installation of Measurement and Test Equipment.
• Design and execute qualifications and validations for M&TE.
• Investigate and troubleshoot equipment issues.

Skills

Communication

Organizational

Time Management

Critical Thinking

Project Management

Education

Bachelor's degree in engineering or related scientific discipline

M.S. preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Building Automation Systems

Job description

Principal Quality Engineer (Finance)

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

We are shaping the industry by contributing to the development of test methods that govern our field. We have become the industry's premier provider, supporting clients throughout every stage of the product development lifecycle and beyond.

Join an organization with:

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, guided by 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. Lead initiatives to develop criteria for procurement and installation of new Measurement and Test Equipment (M&TE) in laboratories, adhering to testing standards.
2. Design, write, and execute qualifications, requalifications, process validations, and building validations for M&TE as per industry regulations (e.g., 21 CFR Part 820, ISO 17025).
3. Analyze qualification, requalification, and validation data and generate final reports.
4. Collaborate with CSV and IT teams to ensure GxP documentation, compliance, and validation of electronic data systems (e.g., 21 CFR Part 11).
5. Investigate and troubleshoot using advanced mathematical and engineering knowledge.
6. Develop quality records such as change control plans, risk assessments, and CAPAs.
7. Apply technical expertise in requalifying, conducting process validations, and troubleshooting sterilizers and resistometers.
8. Manage procurement processes for materials and services required by the department.
9. Maintain and support equipment documentation within the Equipment Management System.
10. Provide training to laboratory staff on equipment use and processes.
11. Proactively address equipment failures through trending and analysis.
12. Install, validate, troubleshoot, and monitor equipment continuously.
13. Assist with ongoing monitoring and alarm investigations.
14. Review engineering software systems periodically.
15. Support department metrics collection and management review processes.
16. Provide equipment records for audits and qualifications as needed.
17. Mentor team members, prioritize tasks, and guide the team in alignment with engineering management.
18. Assist laboratories with proactive equipment planning using standard engineering techniques.
19. Ensure proper archiving and disposal of equipment files.
20. Coordinate with internal groups on equipment and quality issues.
21. Update procedures and training related to engineering processes.
22. Harmonize equipment and documentation practices across global sites.
23. Review industry regulation updates and revise documents accordingly.

Qualifications & Technical Competencies:

1. Bachelor's degree in engineering or related scientific discipline; M.S. preferred.
2. 8-10 years of engineering experience.
3. Proficiency in Microsoft Word, Excel, and Project.
4. Expertise in regulatory requirements for system qualifications, validations, and reports.
5. Technical expertise in Building Automation Systems.
6. Strong communication, organizational, and time management skills.
7. Ability to work independently and as part of a team, mentoring others.
8. Critical thinking skills for designing and completing validation processes.
9. Effective project management skills ensuring timely, within-budget completion.

Working Conditions:

Employees must meet physical demands, including talking, hearing, standing, walking, sitting, handling objects, reaching, climbing, and balancing. Must occasionally lift/move up to 50 pounds. Vision requirements include close, distance, color, peripheral, and depth perception, and focus adjustment.