Bausch Health

  • Quality Engineering Manager

    Job Location US-WA-Bothell
    Job ID
    11154
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    This position is responsible for providing leadership to and managing the quality engineering team and for ensuring product quality compliance.

    Responsibilities

    Note:  The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title. 

    • Provide leadership, vision, and strategic planning to the Quality Engineering team.
    • Maintain Quality Engineering capabilities in federal, state, and international medical device regulations and ensure the company’s compliance to them
    • Maintain the day-to-day quality and supplier quality engineering functions
    • Ensure safety agency compliance including IEC 60601-1 and factory inspections
    • Participate in and provide leadership on product risk management activities in compliance with ISO 14971-1
    • Identify, evaluate, and resolve CAPA issues
    • Provide leadership and guidance to ensure product verification and process validation activities comply with medical device standards
    • Plan resource requirements and ensure adequate resources are provided to support product development and manufacturing
    • Develop quality processes in support of medical device standards and the QMS
    • Research and communicate new safety and environmental standard decisions and rulings and provide interpretations to the QE group and to Solta
    • Act as a mentor to the QE organization
    • Develop team capabilities through training, group meetings and individual coaching and discussion
    • Develop and manage group budgets
    • Develop quality technologies by keeping abreast of technology trends and improvements available within the discipline
    • Report QE performance metrics
    • Conduct performance appraisals of team members
    • Effectively communicate with all Solta functions
    • Participate in design and program reviews
    • Develop the Solta culture through maintaining a positive attitude, fostering camaraderie, and identifying ways to enhance teamwork among employees
    • Additional duties as defined by supervisor

    Qualifications

    Experience, Education, Training, Traits:

    • Bachelor of Science in Engineering
    • A self-motivated, self-directed and detail-oriented individual, able to work in a team environment with minimal supervision
    • Must have excellent work ethic, personal responsibility, initiative, and teamwork skills
    • Extensive experience in medical device development, supplier quality, manufacturing, and distribution
    • Ability to resolve conflict and communicate controversial requirements in a non-confrontational style
    • Expert knowledge of FDA QSR, ISO 13485, the Medical Device Directive, and ISO 14971 requirements
    • Expert knowledge of medical device safety standards including UL/IEC 60601-1 and ISO 10993
    • Minimum of ten years’ experience in quality engineering in a regulated environment
    • Effective verbal and written communication, analytical and interpersonal skills
    • ASQ or other certification a plus
    • Proficient in the use of PC software (MS Word, Excel, etc.)
    • Extensive knowledge of the requirements for international quality systems, including ISO-9001/EN 46001, ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601.
    • Strong collaboration, team building, and development skills.

    Language & Verbal Skills

    Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, and customers.  Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

    Math Skills

    Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  Ability to use MS Excel to perform calculations and interpret project results/data.

    Analytical & Reading Skills

    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.  Ability to read technical and clinical literature and documents and extract important concepts.

    Physical Requirements

    May be required to perform lifting tasks of up to 30 pounds for short durations.  Duties of this job may involve standing and/or walking 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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