Apply the principles of modern quality methods and metrology to Zimmer products. Design, monitor and audit the quality 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. Assures product conformance to requirements through appropriate inspections and test activities, system review, validation activities and implementation and maintenance of ISO and GMP requirements. Has necessary independence and authority to evaluate and judge level of conformance with defined requirements.
Principal Duties and Responsibilities
•Has responsibility for the supervision and guidance of assigned salary and hourly 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 supplier’s initial product samples, tooling samples, Zimmer molds and other parts as required.
e.Maintain all related documentation systems to comply with standards and regulations.
•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 ”a 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. . Evaluate and define as needed validation policies for particular equipment.
•Participate in the internal quality-auditing program performing audits and providing resources for auditing.
•Perform failure analysis to determine cause of product failure and activate effective corrective actions.
Expected Areas of Competence
Must possess good writing skills and be familiar with both the scientific and vernacular vocabularies, English and Spanish. Solid interpersonal skills at all organizational levels. Team work and customer focus oriented. Demonstrate ability in attracting, interviewing, training, coaching, motivate, discipline, and direct people. Good knowledge of applicable government specifications, standards and regulations such as- Quality System Regulation and ISO standards. Proficient in the use of word processor and spreadsheets.
Education & Experience Requirements –
•Bachelors’ degree in Engineering combined with a minimum of two years of experience in Quality Control/ Assurance area, including modern quality control methods.
•Experience in working with Quality Systems related to ISO (preferred).
•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.
•Hands on experience in precision gauging and layout methods such as CMM, optical and electronic non-contact gauges, desirable.
•Prior experience in engineering drawings and specifications interpretation a plus.
Licenses/Certifications – Quality Engineering Certification (ASQ) a plus.
Licensed Engineer and member of the College of Engineering.
Zimmer - 13 months ago
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