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Quality Engineer II

Quality Engineer II

Lancesoft INCBillerica, MA, US
10 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Title : Quality Engineer II

Location : Overview :

Seeking a Quality Engineer II to support manufacturing and quality operations in a regulated medical device environment.

Must Have :

  • 3+ years’ experience in the medical device industry
  • Strong background in NCMR, CAPA, and product quality management
  • Solid knowledge of FDA (21 CFR Part 820), ISO 13485, and EU MDR
  • Experience in a clean room or regulated manufacturing environment
  • Excellent problem-solving, analytical, and technical writing skills
  • Proficiency in QMS and Microsoft Office

Nice to Have :

  • Familiarity with DMAIC, 5 Whys, Is / Is Not analysis
  • Experience with Agile Map, SAP ERP, or MES
  • Key Responsibilities :

  • Lead and manage non-conformance (NC) and CAPA processes
  • Partner with Manufacturing and Quality teams to ensure compliance
  • Conduct line walks , drive process improvements , and maintain audit readiness
  • Support change control and QMS documentation
  • Education :

  • Bachelor’s degree + 2 years of experience (or advanced degree)
  • Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

    Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

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