QA Director – Medical Devices – FILLED

The Wellington Group has been engaged to find a seasoned QA Director – Medical Devices for the Raleigh, NC area. This is a great opportunity to work for one of RTP’s growing biotech / medical device companies with a focus on current and future combination technologies.

The QA Director will be responsible for managing all Quality Assurance activities to include QS, GLP and GMP training and standards, SOPs, Document Control, Audits and support regulatory and quality submissions.

Responsibilities include:

  • Direct activities for sourcing of raw materials, product development, manufacturing & characterization
  • Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review
  • Interface with US and International compliance and certification authorities as necessary
  • Work in a cross-functional team and represent Quality at Product Development team meetings
  • Audit and oversee activities of outside contract manufacturers, suppliers and consultants.
  • Lead efforts toward continuous Quality improvements

The qualified candidate will have:

  • Minimum of 7 years in medical devices, pharmaceuticals or biologics
  • 4-year degree required, MS degree preferred
  • Broad knowledge of cGMP, ISO requirements for pharmaceuticals and medical devices
  • Experience in design control and oversight of design history files
  • Experience working in a product development team ensuring both compliance and rapid progress
  • Demonstrated ability to manage staff and variable workloads

Industry: Medical Device, Biotechnology

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

Job Code: BHJOB1778_217

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