Principal Quality Engineer

NAMSA • Atlanta, GA

81d

About The Position

NAMSA is seeking a qualified individual to champion initiatives for the procurement and installation of new Measurement and Test Equipment (M&TE) for laboratories, ensuring compliance with testing standards. The role involves designing, writing, and executing non-routine qualifications, requalifications, process validations, and building validations for M&TE as required by industry regulations and standards such as 21 CFR Part 820 and ISO 17025. The successful candidate will analyze qualification and validation data, collaborate with CSV and IT for GxP documentation, and troubleshoot using advanced mathematical and engineering knowledge. Additional responsibilities include writing quality records, driving the purchasing process for materials, maintaining equipment documentation, providing training, and assisting with continuous monitoring and alarm investigations. The position requires a proactive approach to problem-solving and collaboration with various departments to ensure compliance and efficiency in engineering processes.

Requirements

• Bachelor's degree in engineering or related scientific discipline required, M.S. preferred.
• 8 to 10 years of related work experience in Engineering.
• Microsoft Word, Excel, and Project experience required.
• Expertly applies regulatory requirements to requirement specifications, system qualifications, validations, protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Technical expert of Building Automation System.
• Strong written/verbal communication, organization, and time management skills.
• Able to excel both as part of a team and independently, with a focus on mentoring Engineering Associates.
• Demonstrates critical thinking skills to identify, design, configure, and complete validation process for Engineering software systems.
• Strong project management skills ensuring timely completion, within budget, coordinating with departments and vendors as needed.

Responsibilities

• Champions initiatives for identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories.
• Responsible for design, writing, and executing non-routine qualifications, requalifications, process validations, and building validations for M&TE.
• Analyze qualification, requalification and validation raw data and generate final reports.
• Collaborates with CSV and IT to complete GxP documentation, compliance, and validation of equipment.
• Investigate and troubleshoot using advanced mathematical and engineering knowledge.
• Write/implement quality records such as change control plans, risk assessments, nonconformance, corrective action and preventative action.
• Expertly applies technical aptitude for requalifying, conducting process validations and trouble-shooting sterilizers and resistometers.
• Drive purchasing process for materials/services needed for owning departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Collaborates with departments to provide training to Associates for equipment use and processes.
• Drive proactive solutions when trending and analysis of TE failures observed.
• Expert installing, validating, troubleshooting, and maintaining continual monitoring points.
• Assists laboratory personnel with continuous monitoring and alarm investigations.
• Completes periodic review of Engineering owned software systems.
• Assists Engineering Management with additional department metrics/data gathering.
• Provide equipment records to appropriate staff for client audits.
• Mentor teammates, prioritize team tasks, and provide guidance.
• Apply standard engineering techniques to assist laboratories with proactive equipment planning.
• Ensure electronic and paper equipment files are retired/archived appropriately.
• Interface with groups within the organization on equipment and quality-related issues.
• Assist updating procedures and training related to local and global engineering processes.
• Assist Engineering Management with harmonization of equipment and processes to other NAMSA sites.
• Assist Engineering Management with internal/external document review for revised industry regulations and standards.

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees