Quality Assurance Specialist

4 weeks ago


Durham, North Carolina, United States LanceSoft Full time
Job Description

Job Title: Quality Assurance Specialist

Location: Durham, NC

Duration: 12 Months

Work Schedule: Monday - Friday, 8am - 5pm

Description:

This role supports the Supplier Quality organization in developing and managing quality assurance processes for the Durham, NC facility. The primary responsibility includes ensuring suppliers comply with client standards and regulatory requirements, as well as ensuring suppliers have the capacity and capability to meet client demand.

The successful candidate will provide leadership, development, and coaching to suppliers and internal Supplier Quality Engineers. They will partner with internal stakeholders to ensure compliance to product, customer, and regulatory expectations.

Key Responsibilities:

  • Leading supplier and process qualifications
  • Leading issue/defect resolution
  • Managing performance monitoring/reporting
  • Compliance to appropriate standards
  • Streamlining/developing processes

Requirements:

  • Bachelor's degree in an engineering discipline
  • Minimum 5 years of experience in a Quality or Supplier Quality engineering role
  • Prior experience in a regulated industry (e.g., medical device, pharma, Automotive, Aerospace)
  • Lead Auditor certification
  • CAPA experience
  • Design Controls experience
  • Demonstrated knowledge of the Quality Engineering body of knowledge
  • Good communication and strong writing skills

Preferred Qualifications:

  • ASQ certifications (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
  • Demonstrated knowledge of DMAIC/Six Sigma and problem-solving methodologies
  • Working knowledge of industry standards (21CFR part 820, ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304)

LanceSoft is an equal opportunity employer.



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