The Quality Engineer will play a key role in supporting both the Regulatory and Quality Departments, focusing on Statistical Process Control (SPC), Calibration, and Project Management with customers. This role is responsible for developing strategies to enhance customer satisfaction, particularly following audits, and for managing projects that involve statistical data analysis and Key Performance Indicator (KPI) development. The position emphasizes both existing product performance and new product development. Key responsibilities include maintaining Standard Operating Procedures (SOPs), work instructions, inspection forms, Device History Records (DHRs), batch records, and ensuring timely document approval. The role is critical in aligning the company's efforts with customer expectations and delivery timelines.
Essential Functions
Collaborate with Manufacturing, Engineering, Quality, and Regulatory teams to analyze, document, and improve daily quality control and assurance processes.
Ensure timely calibration of all instruments, maintaining schedules for metrology and calibration requirements.
Streamline and manage processes to ensure clarity and efficiency, working cross-functionally to drive continuous improvement, meet deadlines, and exceed customer expectations during periodic reviews, internal and supplier inspections, and NC/CAPA management.
Provide documentation and statistical analysis to meet both customer and regulatory requirements.
Support quality management initiatives as directed, contributing to the overall success of the company's quality management efforts.
Position Qualifications
Minimum two-year degree in a relevant field, or equivalent experience required; bachelor's degree preferred. Relevant certifications (QPM, SQE, CQE, CQM, Six Sigma) are highly desirable.
Experience with Six Sigma, process capability statistics, and AQL, particularly in a medical device or pharmaceutical setting with FDA regulations.
Proficiency in statistical analysis techniques to support product coordination and quality assurance efforts (ANSI/ASQC standards).