The Senior Quality Assurance Engineer is responsible for leading projects and managing cross-functional activities which assure the success of the Quality Management System (QMS). This role ensures that all specimen preparation, testing, and support processes meet the company’s high standards of performance, repeatability, and compliance. The Senior QA Engineer collaborates closely with customers, accreditation bodies, and the operations team to achieve conformity to requirements, identify risks, and continuously improve QA processes.
Salary: $80,000 - $100,000/yr DOE
Calculate, validate, and report key quality performance metrics on a routine basis (daily or as required).
Respond to complex quality-related inquiries from both laboratory personnel and customers, providing technical guidance and timely resolutions.
Lead cross-functional teams through root cause analysis and corrective/preventive action (RCA/CAPA) processes to address nonconformances and underperforming trends.
Oversee Proficiency Testing Provider (PTP) and Internal Round Robin (IRR) programs, including:
Identification of participation requirements
Procurement and preparation of test materials
Assessment of homogeneity and stability
Statistical evaluation of results
Implementation of corrective actions for outliers or anomalies
Develop protocols and procure materials for technical studies, experiments, and validation activities.
Maintain the approved vendor list and provide quality oversight for supplier qualifications and material purchases.
Manage the organization’s change management system, ensuring appropriate documentation, risk evaluation, and approval processes.
Support and/or lead internal and customer audits, including preparation, execution, and follow-up of findings.
Lead quality engineering projects aimed at improving process capability, testing accuracy, and system reliability.
Prepare and deliver both formal and informal presentations on quality and testing topics to diverse audiences, including management, technical staff, and customers.
Perform other related duties as assigned by the Quality Assurance Manager to support departmental and organizational goals.
Education: Bachelor’s degree in Engineering, Quality, or a related technical discipline.
Experience: Minimum of 5 years in Quality Assurance, Quality Engineering, or Laboratory Quality Management, with at least 2 years of experience managing or participating in PTP and IRR programs.
Technical Skills:
Strong knowledge of QA/QC principles, proficiency testing, and statistical analysis.
Familiarity with applicable standards such as ISO 17025, ISO 9001, and ASNT guidelines.
Experience with data analysis, trend monitoring, and CAPA systems.
Proficiency in Microsoft Excel and QA data systems; experience with Laboratory Information Management Systems (LIMS) is an asset.
Understanding of calibration, measurement uncertainty, and inter-laboratory comparison principles.
Soft Skills:
Excellent analytical, problem-solving, and decision-making abilities.
Strong communication skills with the ability to explain technical data clearly.
Highly organized and detail-oriented with a proactive approach to process improvement.
Effective leadership and collaboration skills across technical and operational teams.
The Senior Quality Assurance Engineer operates in a professional technical environment that may include laboratory, office, and production settings. This role requires frequent collaboration with laboratory technicians, engineers, and management teams to monitor and improve quality performance.
Physical Requirements:
May occasionally lift or move materials up to 45 pounds.
Prolonged periods of sitting, standing, and computer work.
Occasional travel to field sites, vendor facilities, or customer locations may be required.
Work Conditions:
Standard business hours with flexibility to support testing schedules or audits as needed.
May involve working around laboratory instruments, radiation testing equipment, or other controlled materials (following all applicable safety protocols).
Work may include exposure to moderate noise, temperature variations, and laboratory environments requiring use of PPE (Personal Protective Equipment).
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.