Quality Technician (2nd Shift)

The Quality Technician (2nd Shift) role at Aspen Surgical involves ensuring manufactured products and materials conform to regulatory and customer requirements, evaluating nonconforming products, and performing root cause analysis. The role requires a high school diploma or equivalent and 3+ years of experience in a regulated industry. The ideal candidate will have excellent communication and problem-solving skills, and experience with quality system requirements, including FDA and ISO regulations.

Requirements

• High School Diploma or equivalent
• 3+ years of experience responsible for Quality improvement projects
• 3+ years of experience in a regulated industry experience that includes FDA and ISO requirements
• Communication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
• Flexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and priorities
• Teamwork, communication, positive attitude required to support the manufacturing environment
• Ability to read and analyze technical prints and drawings
• Problem Solving – able to perform root cause analysis and implement effective corrective actions
• Project Management – able to effectively manage and complete multiple projects simultaneously
• Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite, IFS, EtQ
• Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
• Establish, implement, and maintain the quality system in accordance with FDA Quality System Regulation, ISO 13485, European Union Medical Device Regulations, and MDSAP participating countries regulations

Benefits

• Equal opportunity employer
• Celebrate employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status