| Title | Quality Engineer |
|---|---|
| Categories | Engineering, Manufacturing, Quality Department |
| Location | New York, NY |
| Job Information | 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 |
| Apply Now |