Quality Department

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

Quality Assurance Inspector

• Work in manufacturing and production environment
• Be responsible to inspect, test, sample and sort small high precision machined parts and electromechanical assemblies.
• Perform 1st piece inspection, in-coming inspection of material and components, in-process inspection and finished goods inspection.
• Show proficiency and understand manufacturing drawings and tolerances and ISO/ ANSI standards
• Operate inspection tools including calipers, micrometer, go/no-go gauge, thread gauges etc.
• Review and follow internal work instructions and procedures, qualifications and validations written by the company and will document the results.

Position reports to Quality System Manager

Education

• 2 years experience in the same environment industry or similar.
• A High School Diploma or GED is required to fulfill this job opening. Associate degree is preferred. Experience working in a GMP environment helpful

Jarvik Heart, Inc. is a private company that develops miniaturized heart assist devices for the treatment of severe heart failure. The Jarvik 2000 Flowmaker, Jarvik Heart’s successful pilot heart pump, is an investigational device used in the United States to support patients awaiting heart transplants. In Europe, the Jarvik 2000 has earned CE mark certification for both bridge-to-transplant and lifetime use. As an investigational device, the Jarvik 2000 has been implanted in more than 700 heart failure patients with no mechanical failures, and has successfully sustained and improved the condition of patients awaiting transplants, as well as those who have chosen the device for lifetime use