Accessibility Links

Senior Quality Engineer

  • Job type: Permanent
  • Location: Austin
  • Salary: Competitive
  • Job reference: EPM
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 22/12/2017
Our client, an established Medical Device company based in the Austin area, is currently looking to bring on board a Senior Quality Engineer.



Responsibilities:
  • Responsible for maintenance and management of the Site Quality System under ISO 13485, CMDR, IVDD and other global standards.
  • Maintenance and management of document control process, failure investigations, corrective and preventative action plans, customer support programs, supplier quality management system, internal & external audit programs, and product release activities.
  • Conduct internal audits for compliance to established Quality Manual and applicable international and regulatory standards
  • Participate in engineering change reviews
  • Participate in validations
  • Responsibilities for implementation, maintenance and management of LMA Quality Systems according to US FDA, ISO 13485 (under CMDR and IVDD)



Qualifications:
  • BA or BS in relevant field
  • Experience in manufacturing background
  • Certification in quality
  • Knowledge of current industry practices under ISO 13485, CMDR and IVDD Quality System preferred



If interested, get in touch with apply.a33ho1gkvih@phaidoninternational.aptrack.co.uk
Similar jobs
Senior QA/RA Manager
  • Job type: Permanent
  • Location: Utrecht (stad)
  • Salary: £90000 per annum
  • Description Senior QA/RA Manager required I am currently working on a project with an exciting medical device company, who are going through a growth phase following...
Manager, Medical Writing
  • Job type: Permanent
  • Location: New Jersey
  • Salary: $120000 - $140000 per annum
  • Description Our client is located near Trenton, NJ and is one of the industry leaders in the medical device field! We are looking for an experienced...
Medical Director - Medical Communications
  • Job type: Permanent
  • Location: Parsippany
  • Salary: $120000 - $150000 per annum, Benefits: Healthcare + Bonus + PTO
  • Description Job description High performing agency located in New Jersey is looking for a full time Medical Director. As Medical Director, you will lead medical writing...
Principal Regulatory Writer
  • Job type: Permanent
  • Location: Chicago
  • Salary: $120000 - $135000 per annum
  • Description One of the leading companies in Pharmaceuticals is in search for a talented Principal Regulatory Writer to support their Immunology and Oncology teams. This is...
Quality Assurance - Logistics Specialist
  • Job type: Permanent
  • Location: Puurs
  • Salary: Competitive
  • Description Job Description A world leading health-care company who provide solutions to address the evolving needs of patients worldwide. Active in more than 140 countries, with...