Randstad Quality Engineer in Marlborough, Massachusetts

Quality Engineer

job details:

  • location:Marlborough, MA

  • salary:$65,000 - $80,000 per year

  • date posted:Monday, June 4, 2018

  • experience:0 years

  • job type:Permanent

  • industry:Health Services

  • reference:140584

job description

Quality Engineer

Quality Systems Engineer needed in the Hudson, MA area for immediate consideration. The right person supports external quality audits and leads/supports internal quality audit teams to assure that site activities comply with all applicable regulatory requirements, policies and procedures. Must have a BS in Science, Health, or Engineering along with 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) along with experience working to interpret and apply quality regulations and standards. Apply now

Responsibilities for the Quality Engineer

  • Maintaining internal process for continuous compliance with corporate / global quality system and external requirements

  • Communication and documentation of internal and external compliance-related information including changes in external requirements, corporate requirements, and local changes to ensure continuous compliance

  • Involved in handling audit non-conformances, evaluating impact to compliance, and facilitating sustainable fixes

  • Advise management on potential improvements or enhancement to quality systems and processes in the company.

Requirements for the Quality Engineer

  • BS in Science, Health, or Engineering

  • 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) experience

  • Experience working to interpret and apply quality regulations and standards.

  • Previous accreditation as quality auditor (e.g. ASQ CQA, etc)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.