Sr. Quality Engineer - Medical Devices

Planet Pharma

North Haven (CT)

Sur place

USD 83 250 - 132 150

Plein temps

14 jours+

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Résumé du poste

A leading Medical Device company is seeking an experienced Quality Engineer in North Haven, CT. Candidates should have over 4 years of experience in quality engineering and a Bachelor's degree in engineering. The role involves supporting new product development and ensuring compliance with quality standards. The position offers a salary range of $83,250 to $132,150.

Qualifications

4+ years of experience within Quality Engineering in a regulated environment.
Experience in developing and manufacturing medical devices.
Understanding of software and hardware interfaces.

Responsabilités

Support new product development for Surgical Instruments.
Provide guidance implementing strategies for product quality.
Analyze and interpret statistical data for management.

Connaissances

Risk Management

Design Verification

Mechanical Design Understanding

Statistical Data Analysis

Formation

Bachelor's Degree in Engineering

Outils

Quality Engineering Tools

Description du poste

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Overview

Our client, a leading Medical Device company, is seeking an experienced Quality Engineer to join their growing team - see below for other details!

Skills Needed

Risk Management (Hazard Analysis, DFMEA, UFMEA)
Design Verification Authoring and Execution

Responsibilities

The Senior Quality Engineer position on the team supports new product development for Surgical Instruments.
In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team.
An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred.
As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
Actively participate in product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc.
Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses.
Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

Qualifications

4+ years of experience within Quality Engineering in a regulated environment

Bachelor's Degree within an Engineering realm

Nice to have

NICE TO HAVE

ASQ Certified Quality Engineering (CQE)
Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
Understanding of software and hardware interface

Details