Quality Engineer Jobs

Responsibilities

• Work closely with Quality System Manager to maintain company Quality System

• Perform process improvement activities and process validations

• Perform investigations and corrective actions as necessary

• Revise Quality System procedures and other documentation as necessary

• Support development activities under design controls

• Support annual Quality System inspections and external quality audits

• Support Quality Manager with Management reviews and maintenance of corrective/preventative action system

• Support various regulatory and/or clinical activities as necessary

• Other duties as necessary

Desirable skills

• Mechanical or industrial engineer with 3–5 years of experience working for a medical device company

• Enthusiasm for learning and desire to be challenged in a fast-paced medical device company

• Detailed oriented, good analytical skills

• Knowledge of FDA, ISO 13485, ISO 14971, GMPs

• Knowledge in the application of design controls

• Knowledge of equipment qualifications (IQ/OQ/PQ) and process validations

• TQM knowledge or ASQC certifications helpful

• Good technical writing, communication, and interpersonal skills

• Experience using statistical tools to improve quality

• Position reports to Quality Assurance Manager