Quality Assurance Engineer OmniGuide
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Support manufacturing process improvements and validations, including equipment.
Perform physical investigations of product failures.
Manage complaint handling process and perform routine trending analysis.
Assist members of the QA/RA department to establish, implement and maintain the OmniGuide, Inc. quality management system.
Perform internal audits.
Manage CAPA & NCMR systems.
Perform FMEA/Risk Analysis for new/existing products and processes.
Must have a minimum of 3 years experience working within the medical device industry. Experience with catheter or laser products a plus. Sterile device experience preferred.
Experience with 21CFR820 Quality System Regulations and ISO 13485.
Must have effective communication skills (oral and written).
Proficient in MS Office ? especially MS Excel.
Experience with electronic QMS programs, Master Control a plus.
BS in Engineering or related sciences preferred.
Cambridge, Massachusetts, United States
||One Kendall Square, Building 100 |
Cambridge, MA 02139
THIS JOB HAS EXPIRED