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Sr. Quality Systems Specialist - Contract to Hire

An innovative aesthetics based medical device company is looking for a Sr. Quality Systems Specialist due to growth!

The Sr. Quality Systems Specialist will have the following responsibilities:

  • Assists in maintaining ISO 13485: 2016 certification, implementation of MDSAP (Medical Device Single Audit Program, MDR (European Union Medical Device Regulations)
  • Maintain approved supplier program: lists, audits, etc.
  • Manage activities and procedures associated with complaints. Responsible for reviewing and investigating customer complaints
  • Translates quality requirements and initiatives into objectives, action plans, and metrics.
  • Provides ongoing support and review of Quality System documents including SOP's, Work Instructions, and other functional documentation to ensure adherence to industry standards including ISO 13485, the FDA's QSRs, and other applicable quality standards, regulations, corporate policies and guidelines.
  • Provide assistance with external audits and inspections or with any other compliance-related or regulatory processes and activities.
  • Initiate and drive corrective actions when systemic issues are identified.
  • Interface with customers and vendors on quality, regulatory, technical and business issues

The candidate should be interested in becoming a full time employee after 3-6 months of contracting for the client.

Sthree US is acting as an Employment Business in relation to this vacancy.