System One Services Quality Engineer in Waltham, Massachusetts
Quality EngineerWaltham, MA
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
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
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