Senior Quality Engineer

Bachelor’s degree in engineering or related discipline is required
A minimum of five years related experience preferably in the medical device industry or a regulated environment such as aerospace
Strong working knowledge of ISO 13485:2003, QSR, ISO 14971 and related standards
Experience with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required

Follows all Quality Management System Requirements and participates in the development/modification of quality system protocols, quality system Requirements Manual, company Policies and directives
Quality Representative for Material Review Board (MRB) of components manufactured in the Easton facility
Quality Representative for Change Control Board (CCB) of components manufactured in the Easton facility
Owner of all inspection and test methodologies, and gage R&R including gage R&R between facilities
Participates in external audits
Participates and approves specifications (input/outputs), verification and validation, risk management activities including DFMEA and PFMEA, Quality Plans and to assure products meet specifications
Manages larger scale projects or multiple smaller scope projects demonstrating strong project ownership, accountability, and strategic forethought
Provides Engineering studies as needed and statistical justifications
Leads and execute engineering studies relating to Gage R&R, Cpk, SPC and Process Validations
Leads and manage root-cause analysis as assigned relating to customer complaints, inquiries and product returns
Implements ongoing quality improvement processes working with cross functional teams
Conducts investigations and associated actions related to CAPA and Internal/external audit activities

A master’s degree in engineering or related discipline is preferred and may substitute for some of the years of required experience
ASQ Certification (Auditing, Biomedical Auditing, Quality Engineering, Six Sigma Green/Black Belt) highly valued