Position Title
Quality Assurance Engineer
SBU
Corporate
Department
Quality Assurance
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
Statistical Process Control and its practical application to a production environment. Documentation control including the generation and change control of complex blue prints, schematics and product specifications. Product and process validation as required by the cGMP. CADD ( design/drafting) program. Development software, project management and manufacturing software. Plastic part design. Various manufacturing process and methods. GMP and related requirements for assembly, extrusion, and injection molding of critical medical components and devices, as well as the training of personnel in related areas. Principles and practices of professional engineering. Laws, rules and regulations pertaining to product design and development projects and activities. Principles and techniques of modern management, organization, budgeting, and personnel management.
Qualification Requirements
Minimum of seven years direct experience in the medical device industry, with at least three to five years recent experience in mechanical, electro-mechanical or process engineering, preferably as part of quality assurance engineering group. Education: Possession of Bachelor's degree in Engineering or applicable life science discipline; additional coursework or work towards a Masters degree a plus.
Preferred Qualifications
Plans, organizes and completes all activities relating to Quality Assurance Engineering projects and assigned activities. Serves as a technical support to the quality control group including discrepant material review board, corrective actions, and inspection process and training. Serves as Quality Assurance Engineering support to the Production Process, calibration and metrology; designs inspections fixtures and review of inspection procedures to assure that valid quality parameters are being inspected, and that the proper AQL levels are being utilized. Designs corporate statistical process control program; implements ISO complaint systems and controls audits product and process projects. Assist in the development of new products and the release of new product. Investigates and resolves technical problems involving product performance, production equipment or facility systems affecting production. Identifies and promotes training programs to ensure personal professional development to be better prepared to respond to challenges and growth in the future of the organization. Prepares product failure analysis of existing or returned product and failure modes effective analysis of new product; reviews and approves proposed changes to existing products. Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction progress, capital spending and expense status.
Responsibilities
This is the journey level class and is intended to be the primary backup for the QA Manager in his absence. The position is responsible for completion of the QA engineering activities in the manufacturing and distribution facilities, as well as direct interface with corporate sales and customer base as required in support of the PUR process.
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