• Life Science Group Quality Assurance Manager (Quality Manager I)

    Location US-CA-Hercules
    Requisition ID
    2017-4859
    # of Openings
    1
    Category
    Quality & Regulatory
  • Overview

    The Quality Manager is responsible for maintaining quality systems, providing quality oversight and developing and leading the Quality Assurance organization for Discrete Manufacturing. This individual will function in a management role within the QA department and must demonstrate excellent leadership, communication, critical thinking, and organizational skills. It is expected that the incumbent will lead his/her Quality Systems specialists as part of a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The position requires thorough knowledge and experience with validation, process improvement, ISO 13485, as well as developed managerial and project management skills.

    Responsibilities

     

    • Manage a team of Quality Specialists supporting Bio-Rad LSG manufacturing sites in North America and Singapore, ensuring compliance to ISO, Life Science Group (LSG) Quality Management System (QMS), and company policies, in order to achieve quality goals.
    • Effectively practice Performance Based Management by coaching and developing direct reports.
    • Act as Quality representative for Manufacturing Transfer and Process Validation phases of the New Product Development (NPD) process through product release, as well as for sustaining manufacturing and post launch activities.
    • Aid in transition to an ISO 13485 compliant Quality Management System and partner with GSC Management Team to maintain effectiveness moving forward.
    • Support completion of product lifecycle risk management activities in cooperation with functional subject matter experts.
    • Implement an effective Change Control Board and Material Review Board responsible for oversight and planning of changes and nonconforming product management.
    • Participates in the review and approval of technical design documentation such as R&D and engineering inputs, validations, risk analyses, etc. to contribute quality requirements and considerations.
    • Consult, coach and train groups in developing and drafting validation plans, protocols, test methods, and reports. Act as final reviewer and approver on validation documents, when necessary.
    • Oversee the Product History File (i.e. Traveler) Release process.
    • Provide Quality guidance for resolving quality concerns with GSC, GCO and Group partners.
    • Ability to define and resolve complex problems through the implementation of sustainable solutions and effectively communicate resolutions across the organization.
    • Support activities related to core quality systems including Root Cause analysis, CAPA, Nonconformance, Deviations, Change Control and Impact Assessment, as well as, control of Documentation and Records.
    • Participate in the internal auditor program. Independently perform various floor, site and CAPA verification audits.
    • Establish and monitor relevant metrics for team and provide regular updates to LSG QA Management team on status and progress.
    • Provide Quality Management System based training to manufacturing management and staff.

    Qualifications

     

    • Bachelor’s degree in Engineering, Biology, Chemistry, or related discipline.
    • 5+ years’ relevant industry and quality systems experience in a regulated environment (GMP and/or 13485).
    • Minimum 3 years of experience supervising/managing highly functioning QA/RA teams.
    • Minimum 2 years of experience working with ERP (enterprise resource planning) systems such as SAP or Oracle, as well as experience with Product Life Cycle Management (PLM).
    • Experience with clean room operations and other manufacturing systems a plus.
    • Audit experience (i.e. Internal, External, 3rd party).
    • Certification as ISO 13485 auditor a plus.
    • Quality Engineer, Quality Manager, Six Sigma Green or Black Belt Certification desirable.
    • Strong customer orientation and focus.
    • Project management, multitasking, organizational, interpersonal, and leadership skills a must.

     

    About Bio-Rad:

     

    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

     

    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

     

    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

     

    To all recruitment agencies:

     

    Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

     

     

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