System One Services Quality Engineer in Waltham, Massachusetts

Quality EngineerWaltham, MA





Job ID:117043

Date Posted:05/16/2017

Senior Quality Engineer

Minimum of 3+ Years in a Quality Engineering role

Education- BS in Engineering.

"Must have" experience managing and supporting the quality system in a medical device company including CAPA, Training, Documentation Control, Complaints, MRB/NCMR, Internal Audits and Management Reviews.

Experience in a FDA GMP/medical device environment with ISO 13485, is required

Position Responsibilities:

  • Manage the documentation required as part of the Quality System related to Manufacturing

  • Assist in the maintenance of supplier certification/performance measurement program data

  • Manage Receiving and Inspection of incoming materials

Additional duties/experience

  • Assist in manufacturing processes and driving product quality

  • Assist with the preparation and filing of regulatory documents (U.S. and International)

  • Experience in supplier quality assurance requirements (Medical Device industry) a plus

  • Familiar with product specifications and incoming inspection procedures

  • Experience with foreign regulatory filing is a plus.

  • Strong knowledge of MS Office and experience with customizing spreadsheets


  • Company provided health care, dental, short-term disability

Salary is in the 85K range