Beaver Visitec International

  • Sr. Director, Quality

    Job Location US-MA-Waltham
    Posted Date 3 weeks ago(3 weeks ago)
    # of Openings
    1
  • Overview

    Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures.  Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

     

    Beaver-Visitec International currently seeks talented professionals to help create and promote innovative, new microsurgical products for ophthalmic surgery.

    Reporting to the VP of Quality and Regulatory Affairs, The BVI Sr. Quality Director is responsible for the implementation and overall suitability and effectiveness of the BVI Quality Management System as required by applicable medical device regulations, including 21CFR820, ISO 13485:2016, MDD/MDR, etc. The Sr. Quality Director has direct oversight for quality activities at the corporate location and assures compliance to quality regulations at several manufacturing sites. The ideal candidate will be a motivated individual looking to grow professionally in a fast-paced environment. Strong analytical skills, excellent knowledge of theoretical and practical Quality fundamentals, and demonstrated ability to lead are required.

    Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

    Responsibilities

    • Leads the implementation, execution and maintenance of the overall BVI quality management system (QMS) execution, including Management Responsibility (Management Review, Quality Objectives, Quality policy), Quality Engineering, Design Quality Assurance, Quality Systems, Supplier Quality, Complaint Management, Document Controls, Training, Internal audit, Supplier controls, Risk Assessment, CAPA.
    •  Provides vision and direction in order to foster a culture of quality, to satisfy patient/user needs, to meet compliance expectations, and to achieve business goals.
    • Continually monitors the Quality environment and evolving FDA expectations and adjusts strategies and processes accordingly.
    • Provides guidance and counsel to BVI leadership regarding changing priorities, processes and regulatory requirements.
    • Manages external audits with regulatory agencies and certification bodies.
    • Drives continuous improvement projects, and proactively identifies and implements best-in-class quality practices.
    • Utilizes Post Market Surveillance data to improve processes and products.
    • Appropriately structures and resources the BVI Corporate Quality department.
    • Provides technical direction, support and guidance for the BVI organization relative to Quality concerns.
    • Manages the activities and performance of direct staff, including hiring, training, developing, addressing performance issues and evaluating performance.
    • Develops action plans and employs training/development programs and assignments to further enhance technical skills and overall competencies of staff members.
    • Leads the development of SOPs and work instructions and associated quality tools to improve quality outcomes and to increase work efficiency.
    • Oversees the compilation and review of organizational Quality metrics to identify potential gaps or adverse trends.
    • Collaborates and Influences cross functional peer leaders in order to obtain support for process improvements

     

    Qualifications

    10+ years of medical device industry experience, with a minimum of 6 years of previous Quality leadership, with experience in managing multiple levels of staff, preferred.

    BS/MS in Biomedical discipline.

    Sitting for long period of time; standing; reaching; computer work (typing, Phone usage; lifting up to 20lbs. unassisted. Must be able to travel domestically and internationally up to approximately 25%.

    Demonstrated ability and commitment to continual improvement thorough understanding of the US & EU Quality and Regulatory requirements (i.e. 21CFR820, ISO 13485, etc.), Well-developed communication skills, CQM, RAC, Six Sigma beneficial , Demonstrated success establishing and maintaining efficient, effective, and compliant quality management systems.

    Exceptional knowledge of US and international medical device QMS regulations.

    Proven track record managing internal and external audits.

    Strong team orientation and ability to lead in a cross-functional environment

    Ability to read, analyze, interpret and communicate regarding scientific and/or technical journals, financial reports, and legal documents.

    Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

    Advanced skills at budget creation, forecasting and budgetary adherence.

    Ability to effectively present information to top management, public groups, and/or boards of directors

    Ability to look at market demands and quality/regulatory trends, technology information and projections, and forecast advanced quality/regulatory needs a minimum of 1-2 years forward.

    Strong proficiency in determining company's business goals and objectives with ability to devise and implement strategy to achieve targets.

    Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.

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