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Quality Engineer (medical device)

Quality Engineer (medical device)

ATR InternationalBillerica, MA, United States
2 days ago
Job type
  • Full-time
Job description

ATR International is a widely renowned technical staffing and consulting leader. Our firm has grown to serve a range of companies—from startups to Fortune 500 organizations. And we support a plethora of industries, from IT, engineering, telecommunications, and finance to healthcare, insurance, and retail. By bringing passion for excellence, trust, and inclusion to every interaction, we build deep connections with our clients, contractors, and local markets to drive long-term mutual success.

Our passion for inclusion is at the heart of our success. Our woman-led, minority-owned firm welcomes fresh perspectives, and our efforts have earned us WBENC Certification—the most prestigious national recognition for women-owned businesses in the U.S. Today, ATR remains one of the most diverse firms in the staffing industry.

Responsibilities :

  • Partner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances (NCs) and potential NCs
  • Conduct quality line walks to ensure compliance and audit readiness
  • Own and collaborate on Quality Management System (QMS) and Process change orders
  • Represent Quality in process improvement projects
  • Collaborate with cross-functional teams to resolve quality issues
  • Ensure corrective actions and documentation meet regulatory and internal standards

Requirements :

  • Bachelor’s degree in electrical engineering or other equivalent field of study is required
  • 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management
  • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations
  • Proficiency in Microsoft Office Suite and quality management systems (QMS)
  • Experience in Process Validation
  • Experience working in a clean room or regulated manufacturing environment

    • Preferred Qualifications :

  • Experienced with DMAIC, process mapping, 5 Whys, Is / Is Not analysis - scientific problem-solving methodologies
  • Experience with Agile Map change control systems
  • Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES)
  • Strong project management skills, with the ability to manage multiple priorities and deadlines
  • Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders
  • Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry
  • Strong technical writing capability
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    Quality Engineer • Billerica, MA, United States