Job Description

Job Type : Contract

Location/City : MA - Danvers

Category : Biomedical

Region : Eastern

Id : 25703

This position is responsible for various quality engineering functions in support of development such as design assurance engineering activities, as well as manufacturing process improvements, and data/statistical trending.

Primary Duties and Responsibilities:

  • Support and Lead Design Assurance engineering activities
  • Support Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting
  • Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
  • Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
  • Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
  • Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
  • Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
  • Develop statistically sound sampling plans and perform data analysis
  • Assess reliability growth strategies in both systems and software and provide input to the engineering teams

Job Qualifications:

  • Bachelor degree in Engineering or Sciences is required, Masters preferred
  • Minimum of 3-5 years of quality experience in medical device industry in electro-mechanical systems and/or cardiovascular devices preferred
  • Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements

IIt is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population.

How to Apply:
Please send your resume in Word or PDF format to:
Copy and Paste the following job title and code and place it in the subject line of your email so we can identify the job: Quality Design Engineer (#25703-MH1639)

Application Instructions

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