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Engineering, Manufacturing, Quality Department
Title Quality Engineer
Categories Engineering, Manufacturing, Quality Department
Location New York, NY
Job Information


·         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

Title Manufacturing Engineer
Categories Engineering, Manufacturing
Location New York, NY
Job Information

Position directly supports the manufacturing and assembly of medical devices.  Experience working within a quality management system or in the medical device industry is helpful.  Must be able to work productively in a busy manufacturing environment with numerous distractions and show an eagerness to learn and work on a close-knit team while energetically and proactively supporting a dynamic, growing, regulated company.

Desired skills and qualifications:
– Strong organizational skills with attention to detail

– Manufacturing engineering experience of 2 years or more is desired

– Electrical engineering degree or experience is helpful

– Very good written and verbal communication skills

– Proactive and energetic (a self-starter)

– Works well in a group

– MS Office (MS Excel, MS Word, MS PowerPoint)

A degree from an accredited college or substantial engineering experience (manufacturing/mechanical/electrical), is required.

This position reports to the Manufacturing Manager.

Apply Now

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