Apply the principles of modern quality methods and metrology to Zimmer products and process. Design, monitor and audit the quality control systems and procedures required to properly control new parts and systems consistent with Zimmer cost and performance standards throughout the procurement, manufacturing and inspection cycles. The Sr. QA Engineer assures product conformance to requirements through appropriate inspections and test activities, system review, validation activities and implementation and maintenance of ISO standard and GMP programs.
Principal Duties and Responsibilities
•Supervise and guide assigned hourly, salary, non-exempt or exempt personnel leading the successful conclusion of the following:
a.Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
b.Formulate, write and maintain procedures, specifications and standards for the quality control of Zimmer products including non-destructive testing methods, gauge design and procurement, sampling and inspection methods and visual acceptance standards.
c.Maintain calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing Practices.
d.Make dimensional layouts of suppliers’ initial product samples, tooling samples, Zimmer molds and other parts as required.
•Contact vendors and negotiate Zimmer quality requirements and solutions to quality problems throughout the entire procurement cycle including such activities as:
a.Supplier pre-award surveys.
b.Initial sample evaluation.
•First production lot inspection and release.
•Establishing florescent penetrant and other NDT testing parameters and standards.
•Seek resolution of quality issues by suppliers.
•Negotiate for the contracting of outside services necessary for the scheduled or emergency calibration or repair of inspection equipment.
•Determine requirements and conduct feasibility studies leading to the procurement of capital equipment for inspection, gauging and testing purposes. Requisition and procure gauges and inspection equipment to maintain an adequate supply for use by inspection and manufacturing personnel.
•Interview, select and train applicants for assigned technical and clerical positions.
•Maintains "state of the art" awareness in areas of nondestructive testing, gauging and measurement methods such as non-contact optical and electronic devices and other developments in the field of measuring sciences.
•Responsible for the validation program, including equipment qualifications. This includes the maintenance of the validation master plan, tracking validation activities.
•Perform failure analysis to determine cause of product failure and activate effective corrective actions.
Expected Areas of Competence
•Teamwork and customer focus oriented.
•Excellent interpersonal skills at all level of the organization.
•Interpret engineering drawings and specifications.
•Demonstrate ability in attracting, interviewing, training, coaching, motivate, discipline and direct people.
•Must possess good writing skills and be familiar with both the scientific and vernacular vocabularies in Spanish and English.
•Good knowledge of applicable government specifications, standards and regulations such as Quality System Regulation and ISO standards.
•Bachelor’s degree in Engineering with at least 5 years of work related experience. Or Master’s degree in Engineer with at least 3 years of work related experience.
• Must be experienced in all aspects of modern quality control methods such as nondestructive testing, metrology, statistical process control, quality cost accounting, applied statistics and inspection.
•Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.
•Extensive experience in precision gauging and layout methods such as coordinate measuring machines, optical and electronic no contact methods, mechanical, air and electronic contact gauges.
•Experience in process validation activities.
Zimmer - 14 months ago
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