Valeant Pharmaceuticals

  • Engineer I, Quality

    Job Location US-FL-Clearwater
    Job ID
    10280
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    The role of Quality Engineering is integral to the on-going compliance of the manufacturing processes. The Quality Engineer I is responsible for ensuring compliance of our products and processes from manufacturing to post-market in medical device regulated environment.

     

    Primarily supports Clearwater, Surgical and Vision Care Quality. May be requested to support other Bausch & Lomb facilities as needed. The position will also include routine interaction and communications with internal business stakeholders and external business partners.

    Responsibilities

    • Supports efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
    • The Quality Engineer must be self-directed, and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System.
    • Supports/leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action.  Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation
    • Evaluate proposed changes for design control requirements. Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria. 
    • Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.) and identifies trends.  Presents this information to management, supervisors, and manufacturing operators.  Supports/leads initiatives to improve performance.
    • Supports/leads teams to update risk management files & PFMEAs for process changes.  Focus team on implementing capable processes, process controls, and error-proofing measures.
    • Post-launch maintenance: Evaluates complaint trends and supports/drives improvements.  Investigates complaints as necessary.
    • The Quality Engineer must possess excellent written and verbal communication skills, and be able to guide others to make sound Quality decisions.
    • Provide daily support to managers/staff regarding Document Change Requests and the Document Control System.
    • Maintains electronic information including training, documents, scanning, deviations, DCRs and DCOs.
    • Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.
    • Key Relationships: 
      -Internal: Functional representatives within Bausch + Lomb facilities.
      -External: Suppliers, external auditors/regulatory authorities, and customers.

    Qualifications

    Required Education:

    • Four-year college degree (BA/BS) in fields such as life or physical sciences, or engineering.

    Required Experience:

    • 3-5 years Quality experience, 1 year minimum experience in Medical Device and/or Pharmaceutical Industry.

     

    Preferred Experience:

    • Working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, problem solving tools, and statistical techniques and application experience.
    • Special Skills: Quality Tools -(Quality Planning, Costs, Assessment, Basic +/or Advance Statistical Techniques, Tech Writing, Metrology & Calibration, Inspection & Testing, Sampling Principles & AQL, TQM, Six Sigma)
    • Problem Solving Tools - {Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis), Computer & Information Technology Skills - (Windows, Word, Excel, Access, Power Point, Project, Visio , statistical software usage & principles
    • Strong written and oral communication and interpersonal skills.
    • Working knowledge of FDA regulations and experience with managing external agency audits necessary.
    • Certified ASQ CQE and/or Lean Six Sigma Green belt preferred. 
    • Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.)

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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