Sr. Mfg Engineer
Listed on 2026-07-01
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Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Sr Quality Engineer – Direct – Lawrence, MA
Maintains and improves Quality Management System to support Class III medical devices.
Coordinates quality data collection, analyses and reporting for Management Reviews and Post Market Surveillance
Manages the Corrective and Preventive Action (CAPA) system
Leads the Quality Audit system by managing the audit schedule and participating in and leading internal audits. Supports 3rd party audits (ISO, FDA, etc.)
Supports Design, Complaint, NCMR investigation project as needed
Identifies product and process improvements; leads and supports their implementation
Some travel may be required (approximately 5%)
BS in Science, Engineering or technical discipline with at least 5 years experience in Quality, Engineering, Design in the medical device, pharmaceutical industry, or equivalent combination of education and experience
Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations.
Demonstrated expertise in one or more of the quality processes required: CAPA, Audit, Complaint, Design Control.
Experience in Post Market Surveillance or Design Control desired
Experience in EtO or Gamma sterilization of disposable medical devices desired
Experience creating and working with databases, queries and reports is a plus
Experience with electronic QMS software system is a plus
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