Enovis · 2 days ago

Manager, Quality Assurance

Houston, TX

Full-time

Onsite

Senior Level

4+ years exp

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Health CareManufacturing

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Responsibilities

Lead incoming inspection and operations quality engineering teams

Utilize comprehensive knowledge of engineering and problem-solving principles to design, implement, and maintain quality assurance procedures

Supervise inspection personnel and formulate strategies to increase efficiencies in the QC Department

Review inspection strategies and techniques used on implant and instrument products

Coordinate the maintenance of the calibration program for all inspection tools and gauges

Develop and administer effective data collection and reporting systems to meet regulatory requirements

Implement defect prevention strategies utilizing SPC/SQC principles and practices

Qualification

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Supervision/LeadershipRegulated Industry KnowledgeISO 13485Quality ControlNon-Destructive TestingMetrologyStatistical Process ControlQuality Costs CalculationInspection Report CreationInspection Measuring EquipmentCalipersMicrometersGagesCMMOasisVision XKeyenceManufacturing ProcessesPrecision MachiningGrindingProduct CleaningSterilizationMicrosoft Office SuiteQuality ManagementContinuous ImprovementSix SigmaLeanSolidworksNetSuiteAgile PLM

Required

Bachelor's degree in engineering or related discipline with a minimum of 4+ years of work experience within a quality function

2+ years of supervision/leadership experience

Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 quality standards

Familiar with quality control methods, including; non-destructive testing, metrology, statistical process control, calculating quality costs, and inspection report creation

Ability to use inspection measuring equipment, including: calipers, micrometers, gages, and other computerized measuring equipment (CMM, Oasis, Vision X, Keyence) is a plus

Basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization

Required and demonstrated knowledge of Microsoft Office Suite

Preferred

Quality discipline certifications a plus, including: CQE, CQA, Lean, 6 Sigma Certification (Green or Yellow Belt), or experience and knowledge of continuous improvement methodology

Preferred knowledge of the following software packages: Solidworks, NetSuite, Agile PLM