• Quality Assurance Manager

    Job Location(s) US-OR-Newberg
    Posted Date 1 day ago(1 day ago)
    Job ID
    2017-1873
    # of Openings
    1
    Shift
    Day M-F
    Category
    Quality & Regulatory
  • Overview

    This position is responsible for A-dec’s reputation as a supplier of reliable, quality dental equipment through the management of activities necessary to ensure conformance with A-dec’s Quality Management System to customer requirements, internal requirements and external standards. This position focuses on elevating problem solving capabilities of A-dec employees and quality improvements throughout the organization.

    Responsibilities

    • Drive continuous quality improvement capability development across A-dec, through training and using established processes such as corrective and preventive action and root cause analysis. This requires the ability to lead cross-functional teams organized to respond to quality performance issues.
    • Manage activities that support external standards (ISO 13485, FDA 21 CFR parts 1-99 and 820, CMDR SOR/98282, Medical Device Directive 93/42/EEC and CE requirements), internal requirements, as specified in the Quality Manual, and the customer requirements of A-dec’s Quality Management System. These activities are performed through the management of strategic action, documentation (Quality Documentation), and quality standards adherence.
    • Foster the creation and application of improved quality methods, systems, and solutions to increase customer satisfaction and market competitiveness of A-dec, and participate in regulatory audits as requested by the Regulatory Affairs Manager.
    • Develop and maintain the appropriate metrics to track corporate quality and report to the executive team on major product quality issues and provide regular (quarterly) updates on overall quality related issues.

    Qualifications

    • Requires a bachelor’s degree in business or engineering or equivalent and a minimum of seven years of experience in Quality or related field with at least five years in a management position.
    • Advanced knowledge of the following: international quality standards including, ISO9001 and ISO 13485, statistical analysis, root cause analysis, and quality measurement.
    • Adept to all Microsoft Office Suite applications and experience in project and database management.
    • Ability to organize, coach, and lead cross-functional teams in addition to having strong organizational and communication skills, including public speaking.

    Drug Screen and Background Check required.

    A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor”  

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