Bausch Health

  • Engineer I Quality

    Location US-MA-Wilmington
    Job ID
    12107
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    To provide specific, yet flexible, Quality Engineering expertise in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance of existing operations.    

     

    Responsibilities

    Process Improvement:

    • Participate in and provide quality support in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices. 
    • Lead and work with teams to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. 
    • Recommend, plan and lead corrective and preventive actions for continuous improvements including investigations and root cause analysis. 
    • Generate quality reports, evaluate and trend quality data, and propose solutions to drive process improvements.
    • Drive and monitor change management process to ensure thorough completion of all changes resulting in timely closure of change requests.

    Validation:

    • Reviews and approves validation protocols, reports, and data related to software, equipment, process, and product validations.   
    • Provide guidance in the proper application of statistical analysis and scientific design of all verification and validation test documentation. 
    • Responsible for the Site Validation Master Plan. 
    • Perform revalidation and risk assessments to support the site validation master plan.

    Project Management:

    • Administrator of CAPA review board for the site. 
    • Participate in or lead cross-functional project teams in identifying and executing programs/tactics to improve existing operations with respect to quality, cost, and delivery. 

    General Quality Support:

    • Facilitate risk management activities including creating and maintaining risk plans, reports, and failure mode analyses for multiple product lines.
    • Create, revise and approve documents as required by changes to policies or in response to compliance issues ensuring adherence to regulatory, regional and internal requirements. 
    • Plan and execute internal audits at the site against applicable Quality System standards/regulations and internal requirements. 
    • Review and approve nonconforming reports and CAPA plans

    Scope of Position:

    Functions independently with minimal direction and as part of a team at the Wilmington Manufacturing site. 

     

    Key Relationships:

    This position must be able to liaison with several internal functional areas including Manufacturing, Engineering, Facilities, Quality Control, Customer Fulfillment, and Purchasing. 

    Effectively interact with external auditors, suppliers, customers and all other employees including corporate officers.

    Qualifications

     
    • Bachelor’s degree or equivalent in science or engineering
    • Competency in Process Validation (IQ/OQ/PQ), Statistical Process Control and Capability Analysis
    • Work and problem-solve independently and as part of a team. 
    • Excellent time management skills, work ethic and be proactive. 
    • Excellent oral and written communication skills. 
    • Must be able to write clear, concise and grammatically correct technical cGMP documents.
    • Proficient in Microsoft Office applications.
    • Strong understanding and application of the Quality System Regulations (QSR – CFR 820) and ISO 13485/ISO9001 requirements.

    Experience:

    • Minimum of 4 years of cGMP experience in the pharmaceutical or medical device industry. 
    • Prior experience working in a Quality/Compliance, Validation, Engineering or technical role within the pharmaceutical or medical device industry.
    • Working knowledge of the requirements of FDA QSR CFR 820, ISO 13485 and ISO 9001. 
    • Lean Manufacturing / Six Sigma experience preferable

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