Senior Engineer (Quality)

Responsibilities

• Utilizes project management skills to ensure timely completion of projects/programs, in support of corporate, plant, and/or departmental goals
• Supports and/or participates in in-depth internal and external audits
• Aids in the preparation for Management Review meetings
• Maintains monitoring of various quality metrics, identifying opportunities for continuous improvement and customer satisfaction
• Compiles and represents data for monthly CAPA Review and Product Review meetings, as well as annual reports
• Gathers and analyzes data for root cause analysis. Drives efforts to assure CAPAs are opened and completed appropriately
• Works with Engineering and Manufacturing to develop and implement corrective actions
• Supports complaint sample evaluations and investigations. Tracks complaint data to identify actionable trends
• Performs risk assessments and analysis
• Serves as quality representative for New Product Development. Contributes to requirements definitions and ensures that reliability, quality, and safety requirements are met
• Works closely with Engineering to develop test protocols and reports
• Actively contributes to Change Review Board as part of change control process
• Ensures compliance to regulatory requirements. Upholds quality system. Supports internal and external audits

Requirements

• B.S. degree in Engineering (Mechanical, Electrical, Biomedical, or Materials preferred); CQE certification a plus
• 3+ years’ experience in Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry. Quality engineering or Product Development experience preferred
• Knowledge of lean manufacturing, Six Sigma principles and Project Management a plus
• Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods
• Knowledge of quality control process and statistical techniques
• Understanding of manufacturing processes and techniques
• Analytical and problem solving skills. Strong attention to detail
• Proficient with Excel (PivotTables, trending, charting) and other statistical software
• Excellent verbal and written communication skills
• Interpersonal skills and the ability to work with cross-functional teams