Bausch Health

  • Quality Technician

    Job Location US-WA-Bothell
    Job ID
    10970
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Responsibilities

    • Review Device History Record for compliance to process and good documentation practices
    • Ensure that quality records comply with GMP and ISO requirements
    • Organize and maintain quality records including scanning, filing, and checkout
    • Audit product line documentation and activities to ensure compliance to manufacturing and quality processes
    • Document results of audit and monitoring activities per company procedures
    • Monitor compliance of products, including device labeling, to established requirements
    • Collect and analyze quality data using statistical tools including sampling plans, process control charts, and capability analysis
    • Improve products and processes through application of data analysis
    • Perform administrator tasks within the electronic training application ComplianceWire
    • Develop and implement new quality processes including a DHR scanning process
    • Perform back up Change Analyst duties
    • Administer the purchase order process for the Quality department
    • Additional duties as defined by supervisor

    Qualifications

    • Capable of reading and interpreting drawings, procedures and specification sheets
    • Knowledge of the FDA GMP (Good Manufacturing Practices) regulation
    • Capable of using computer applications such as spreadsheets and databases
    • Basic statistical knowledge to include trends, pareto and other basic charting techniques
    • Five years of quality assurance experience, in a medical manufacturing environment a plus
    • Knowledge of ISO 13485 a plus
    • Experience using Agile or other PLM a plus
    • Understands change orders and the signoff and release process; familiarity with drawing and BOM structures associated with electro-mechanical software-controlled systems
    • Experience performing internal quality audits a plus
    • Minimum of an Associates degree is required
    • A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
    • Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
    • Effective verbal and written communication and interpersonal skills.
    • Proficient in the use of PC software (MS Word, Excel, etc.).

    Language and Verbal Skills
    Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures. Ability to write procedures, reports, and business correspondence in English. Ability to effectively present information and respond to questions from groups of managers, and internal customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

    Math Skills
    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

    Analytical and Reading Skills
    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to read regulatory, technical and clinical literature and documents and extract important concepts.

    Physical Requirements
    May be required to perform lifting tasks of up to 20 pounds for short durations. Duties of this job may involve sitting for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

    Work Environment
    Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.

    Safety
    Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

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