Bausch Health

  • Supplier Quality Specialist

    Job Location US-NY-Rochester
    Job ID
    11118
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    The  Supplier Quality Engineer –External Manufacturing will work directly with Valeant/Bausch + Lomb  External Manufacturing (EM) suppliers, to provide sustaining quality leadership and routine support related to current commercialized product as well as newly developed products.

     

    In addition, the position will ensure finished EM suppliers are compliant to all regulatory (US and International) and Valeant/B+L requirements.

    Responsibilities

    • Identify and implement effective quality systems at the finished EM supplier sites to support the development, qualification, and on-going manufacturing of EM  products to meet or exceed internal and external requirements.
    • Support USA supplier management team in identifying opportunities for improvements.
    • Complete Batch Releases, Non-conformances, Quality Change Requests and CAPAs including root cause investigations related to EM suppliers within required timelines.
    • Proactively investigate, identify and implement best-in-class Quality practices.
    • Escalate quality supply chain issues with Valeant/ B+L  EM suppliers to Senior Quality Management.
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with EM suppliers.
    • Track and Trend all quality inputs (Complaints, Non-conformances, CAPAs, root cause, change management) and identify adverse trends and institute corrective and preventive actions and effectiveness verifications.
    • Directly support management team for activities related to Management Review, Complaint Review Board, Material Review Board, Local Change Board and Critical Action Committee.
    • The scope of this position is directly related to the External Manufacturing Supplier Quality Organization. The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).

    Qualifications

    • Bachelor of Science degree in a technical discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc.) is required.
    • Experience with Root Cause Analysis and Technical Writing in FDA regulated environment is required.
    • Excellent communication skills (verbal and written).
    • Ability to successfully influence others within project teams regarding quality or compliance concerns.
    • Excellent organizations and presentation skills.
    • Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities.

    Experience:

    • A minimum of 2 years related Quality Engineering experience (Medical Device or Pharmaceutical industry is required).
    • Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
    • Ability to travel to supplier sites is required.
    • Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.
    • Familiar with 21 CFR Part 111, 210, 211 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations, ICH Q7A.
    • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and development and implementation of preventative or corrective actions.
    • Expertise in providing creative solutions to complex issues.

    Key Relationships

     

    Internal Customers/Business Partners:

    • Regulatory Affairs
    • Research and Development
    • Global Product Surveillance and Safety, Pharmacovigilance
    • Design Quality Assurance
    • Compliance Senior Leadership

    External Customers/Business Partners:

    • Finished RX, OTC, Cosmetic and Medical Device EM Suppliers
    • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

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