Senior Quality Engineer - Wayne, NJ - Wayne, NJ - Getinge

Date de Publication 10/18/2019

Résumé de l'offre

  • Type d'employé :
    Employé à plein temps
  • Expérience :
    Not Specified
  • Date de Publication

Description de l'offre

Position Overview:

Lead and oversee Operations Quality Engineering activities for Intra-Aortic Balloon Pumps and/or Collagen to ensure products are manufactured in compliance with all relevant regulatory and legislative requirements.

Job Details:

  • Ensure production is in line with GMP requirements and actively provide tactical direction to support the business targets.
  • Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements.
  • Participate in all regulatory body site inspections and customer audits.
  • Evaluate the level of cGMP compliance for products manufactured, packaged, tested and released through Key Performance Indicators (KPIs).
  • Maintain compliance with 21 CFR Parts 11, 801, 806 and ISO 13485.
  • Partner with the site Complaint Handling team including Post market Surveillance for product improvements.
  • Ensure timely execution and accuracy of Health Hazzard Evaluations including recommendations for any field actions.
  • Work on continuous improvement, validation and verification processes.
  • Responsible for identifying training requirements and training completion for direct reports.

Background Experience:

  • Bachelor’s degree in Engineering preferred; M.S in Engineering or MBA is a plus.
  • 8+ years of experience in medical devices.
  • 3+  years’ experience leading a team of quality assurance professionals at various levels.
  • Excellent communication and interpersonal skills (oral and written)..  
  • Strong interpersonal and communication skills
  • Excellent quantitative and analytical skills.
  • Ability to prioritize tasks in a fast-paced environment.
  • Knowledgeable in Microsoft Office (Outlook, Word, Excel and Power Point)
  • Ability to collaborate with Operations, Engineering, Regulatory Affairs and other business functions.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.