Position Title
Quality Assurance Engineer
SBU
OEM
Department
Quality Assurance
Relocation Covered
No
Educational Requirements
Associates degree
Experience Requirements
Equivalent quality engineering work experience of 5-8 years. Minimum of three (3) years as a Quality Engineer with medical device experience in manufacturing operations, process qualification, and quality engineering.
Qualification Requirements
Education: M.S. or B.S. degree in Engineering. Skills: Regulatory cGMP, QSR and ISO knowledge base, Computer literate/proficient with Word and Excel software programs, Negotiation and problem solving skills, Good oral and written communication skills; ability to properly speak and write in the English language, Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R), Experience in the area of manufacturing operations, Ability to multi-task, prioritize and work independently
Preferred Qualifications
ASQ Certification a plus
Responsibilities
The Quality Engineer is responsible for managing equipment/process validation. Leader of the CAPA program for customer complaints as well as internal corrective actions. Coordinates and improves quality in the areas of suppliers, gaging requirements and design. Familiar with standard concepts, practices and procedures for compliance purposes. Relies on experience and judgment to plan and accomplish goals. Works independently with minimal supervision. ESSENTIAL DUTIES AND RESPONSIBILITES: Directs equipment/process and validation IQ's, OQ's & PQs for adherence to FDA QSR's. Coordinates with suppliers and identifies areas for quality improvements. Determines gaging requirements and assists in gage design. Leader of CAPA that determines root causes, corrective actions and follow through. Reviews and dispositions nonconforming materials. Performs internal audits to ensure quality compliance. Develops calibration standards. Monitors and improves the scrap and rework area. Leads in development of control plans. Assists in contract/order reviews.
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