Quality Engineer, R&D, Medical Device

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company based in Massachusetts who innovates in the area of arterial fibrillation. Their focus is dedicated to advancing innovative treatments while creating more accessibility to patients in need. They have recently acquired a world leading organization and are working on the next generation of cardiac ablation system. The company is positioned well for rapid growth, while also allowing employees to be a part of purposeful mission in developing lifesaving technologies.

DUTIES / EXPECTATIONS OF THIS ROLE

· Support new product development, design changes to existing products, and process development.

· Participate in the risk management process. Develop and validate new test methods, to include performing product testing. Determine sample sizes needed to verify and validate new products and processes.

· Support manufacturing activities to continually improve product quality.

· Develop and implement inspection procedures.

· Participate in the disposition of non-conforming material and the investigation into root causes and implementation of corrective and preventive actions.

· Support incoming, in-process, and final inspections of components and finished goods. Maintains the procedures, policies and systems needed to meet the requirements of the Company’s Inspection System.

· Manages maintenance and archival storage of incoming records and documents.

· Support complaint handling process with assistance in determination of root cause of confirmed complaints, and work with other functions to determine and implement corrective actions.

· Draft and author complaint response communication to customers for completed complaint investigations.

· Assist in implementing and maintaining the quality management system, including corrective and preventive actions, calibration, preventive maintenance, and internal and external quality audits.

MUST HAVES - QUALIFICATION SUMMARY

· Bachelor’s degree in an engineering discipline, or equivalent work experience in quality engineering.

· Medical device catheter experience.

· Applied knowledge of statistics and statistical techniques.

· Understanding of design and process control requirements for US and international product distribution.

· Ability to work within strict deadlines. Requires individual that can accurately and efficiently work on multiple projects and/or activities.

NICE TO HAVE

Class 3 electrophysiology devices a strong plus.

TRAVEL & LOCATION

On site in Marlborough, MA

START & TERM

ASAP. Full time 12-month contact-to-hire