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(2) Quality Engineers

Bedford, MA

Posted: 03/01/2022 Industry: Manufacturing Operations Job Number: 14012

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

 

Title: Quality Engineers

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Perm
  • Pay rate: $90k
  • Job Location: Bedford, MA
  • Job#: bh 14012

 

Quality Engineers


Overview

As Quality Engineer, he/she will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements to stay in compliance.

Responsibilities

  • Executes day-to-day activities based on quality objectives (goals) complementary to corporate policies and goals of building high-quality medical devices.
  • Evaluates medical device failures (product complaints) and writes a summary report
  • Determines root cause and implements Corrective and Preventative Actions (CAPA)
  • Reads and Interpret Standards in biocompatibility, sterilization, and mechanical product testing for developing and updating Standard Operating Procedures and Reviewing or Creating Protocols/Reports.
  • Evaluates risk in product design and the manufacturing process of medical devices
  • Audits the manufacturing process to confirm compliance to procedures used to manufacture medical devices for assembly, packaging, chemistry formulation of solutions, inspections and testing of the medical devices.
  • Updates the quality system based on non-conformities found during internal and external audits
  • Reviews Non-Conforming Material Reports for plan and disposition
  • Analyzes and reports quality system data to the quality and manufacturing teams
  • Evaluates supplier performance based on data collected at incoming inspection.

Qualifications

  1. degree (B.A.) from four-year college or university in mechanical engineering or biomedical engineering or related field; and a minimum of two year of experience in the medical device industry. Understands common medical device standards ISO13485, ISO10993 and ISO14971. Experience in using MS Word, Excel, Power Point and Outlook. Strong oral and written communication skills.

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

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