Skills:

Company: Piper Life Sciences

Location: Elkton, MD

Industry: Life Science

EmploymentType: Full-Time

Salary: 100,000

Description:

Piper Life Sciences is looking for an experienced New Product Development (NPD) Senior Quality Engineer to join an international medical device manufacturer in Elkton, MD.  The NPD Senior Quality Engineer will partner with the New Product Development organization to provide support in all aspects of medical device product development.

Responsibilities of the NPD Senior Quality Engineer:

  • Ensures adherence to US and OUS regulatory requirements, as well as company quality procedures
  • Develops quality systems to monitor products throughout their life-cycle
  • Maintains working knowledge of product technical standards to ensure effective incorporation into new product development
  • Creates functional Design History Files, as well as the development of quality test methods
  • Leads multiple teams in master planning sessions, as well as in the completion of risk management activities  
  • Develops technical investigational plans in response to identifying non-conformance trends
  • Provides input to design requirements by using knowledge of previous issues, both internally and externally reported
  • Ensures that purchased items meet expectations by participating in supplier selection process

Requirements for the NPD Senior Quality Engineer:

  • 4+ years of experience in product development or a research and development organization
  • 10+ years of experience in the medical device quality assurance environment
  • Experience with Minitab, FMEA, DOE, SPC
  • Working knowledge of medical device standards (21 CFR 820, ISO 13485)
  • Bachelor’s Degree in engineering or related life sciences field

Compensation for the NPD Senior Quality Engineer:

  • Salary Range: $90,000-$115,000 commensurate with experience
  • Benefits: Health, Dental, Vision, 401k, 10% bonus, relocation assistance 

 

Please send all qualified resumes to Michael Epstein: mepstein@pipercompanies.com

Keywords: senior quality engineer, quality engineer, new product development, design history file, technical standards, quality assurance, quality control, medical, medical device, research and development, test methods, test development, process development, process implementation, medical, dental, vision, PTO, 401k