Jobs Description

Senior Quality Engineer

AIM Plastics is an ISO 9001 / ISO 13485 certified company that fully understands that quality is the foundation of our business. We provide service to the medical device industry. AIM Plastics is looking for a full-time, direct hire Senior Quality Engineer with plastic injection molding experience to start immediately. Industry competitive wage and benefits apply.

BASIC FUNCTION:

  • Interface with customers on dimensional requirements, results and approvals as required.
  • Quality lead for audit findings, including internal and external corrective and preventative actions (CAPA).
  • Interface with engineering, manufacturing and quality assurance to ensure manufacturing processes and products comply with specified requirements.
  • Develop and control production PPAP documentation.
  • Lead and support quality functions on production floor.
  • Data collection and analysis, working knowledge of Minitab and DIS reporting preferred.
  • Knowledge in statistical methods, GD&T and blueprint reading.
  • Develop, implement and control revisions to production and inspection work instructions and procedures.
  • Assist risk analysis on current and new product and processes.

QUALIFICATIONS

  • Associates Degree and (5) years of job related experience in plastic injection molding.
  • Hands on experience with writing and executing APQP documents and Corrective/Preventative Action process.
  • Understand and be able to apply statistical techniques.
  • Extensive knowledge of and adherence to quality systems and working knowledge of ISO 9001 and ISO 13485.
  • Excellent technical writing skills.
  • Proficient in Microsoft Office, Word, Excel, etc.
  • Able to lift 30 pounds minimum on a regular basis.
  • Proficiency in print reading / GD&T a must.
  • Background in medical device field preferred.
  • Must be dependable with strong organizational skills, ability to follow through a must.