• Quality Systems Manager

    Location US-NH-Merrimack
    Posted Date 5 days ago(11/12/2018 11:21 AM)
    Job ID
    2018-6743
    # Positions
    1
    Business Unit
    KMC
    SECURITY CLEARANCE
    NONE
  • Overview

    KMC Systems, a wholly-owned subsidiary of and co-located with Elbit Systems of America, is a leading contract designer and manufacturer of medical devices and instrumentation for OEM’s in the areas of diagnostic, therapeutic, and biomedical products. With more than 25 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot and field service repair and full compliance with FDA QSR regulations and GMP practices.

     

    Elbit Systems of America (ESA) is a world leader in the design and manufacture of avionics flight instruments, technologically sophisticated defense systems and diagnostic medical instrumentation. ESA combines the close-knit teamwork and high visibility of a small company with the stability and resources only a large company can provide. Add in our employee-friendly corporate culture and great southern New Hampshire lifestyle, and you’ll see why joining ESA could be the best move of your career.

    Responsibilities

    Under the direction of the Q&R Director, the Quality Systems Manager is responsible for the maintenance of the Quality System and is considered the principal subject matter expert on Quality System Requirements, Regulatory Compliance, and Standards. Key objectives include maintaining QMS procedures and records, and overseeing the monitoring and measurement of the QMS (including Audits). Interfaces in a variety of capacities such as lead, host, or SME, etc with ISO audits, customer audits, and regulatory inspections. Responsible for corrective action tracking from audits or inspections. Responsible for the oversight, maintenance, and reporting for all ISO and regulatory documentation implementation, revision and incorporation into Company policies. Participates in concurrent engineering, assisting Program Quality in ensuring that all customer-related Quality System requirements above the Elbit Systems of America- Merrimack Quality System are documented and identified as specified by the Elbit Systems of America- Merrimack Quality System.

     

    1. Act as primary support to the Q&R Director for internal and external customers during audits and inspections. Facilitate regulatory compliance audits and inspections as needed.
    2. Under the direction of the Q&R Director, manage the internal audit schedule. Conduct scheduled and ad hoc internal audits and assessments, or manage the outsourcing of internal audits, as appropriate.
    3. Participate in FDA Inspections as identified and support any follow on response or commitment activities as required.
    4. Business Liaison to QMS Systems/IT Administration and establish plans for future needs.
    5. Oversee the Regulatory Standards Library and train applicable personnel on the use of Standards.
    6. Update QMS Standard Operating Procedures as required to ensure continued regulatory compliance.
    7. Ensure quality system compliance to ISO 13485, European regulatory directives/regulations such as MDD/IVDD, ISO 14971, RoHS, REACH, and applicable parts of 21CFR. Be able to identify standards and regulations that are applicable based on the product description obtained from the customer, and ensure these are captured in Requirements Documents.

      Monitor the Corrective Action process at the request of the Director of Q&R.
    8. Monitor and measure the effectiveness of the QMS.
    9. Gather, analyze, and prepare Quality data for periodic Quality Monitoring and Management Review. Facilitate the collection of Quality Data for Senior Management.
    10. Manage processes and compliance for Quality Management System documentation.
    11. Plan, support and conduct training related to the QMS.
    12. Adhere to internal ethics policies and procedures and external regulations and laws.
    13. Support program execution as needed to facilitate QS Compliance as required, such as Design Assurance Review.
    14. Other duties as assigned, minimal travel anticipated (<5%).

    Qualifications

    • Bachelor's Degree in appropriate discipline (engineering, healthcare, business, etc), quality assurance curriculum and 10 or more years  of directly related experience, or a combination of equivalent education and experience, in the Medical Device industry.
    • A thorough knowledge of the ISO Standards and applicable industry regulations
    • Strong communication and collaboration skills
    • Experience applying medical device standards throughout the product lifecycle to support worldwide market clearances such as 510(k), CE Mark, and PMAs.
    • Proven ability to translate technical documentation such as regulations into effective, compliant documentation necessary for regulatory submissions.
    • Experience and/or certification in auditing to applicable standards and regulations.

     

    DESIRED SKILLS (not required):

    • Detailed knowledge of the applicable industry standards and regulations.
    • Excellent verbal and written communication skills with solid technical writing skills.
    • Excellent problem solving/analytical abilities. Root Cause Analysis essential.
    • Ability to manage multiple tasks in a time sensitive environment.
    • Ability to work productively and proactively with technical, multi-disciplinary product teams.
    • Solid product management and organizational skills.
    • Training experience considered a plus.
    • Certifications considered a plus.

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