• SENIOR QUALITY SPECIALIST - Medical Device

    Location US-NH-Merrimack
    Posted Date 2 weeks ago(8/2/2018 1:55 PM)
    Job ID
    2018-6663
    # Positions
    2
    Business Unit
    KMC
    SECURITY CLEARANCE
    NONE
  • Overview

    Assure cGMP Quality Assurance policies, standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area are maintained and product integrity is preserved. Ensure the highest quality levels area achieved and cost‑effective compliance is applied to align with contractual and Company requirements. Provide QA support to operations and engineering programs as assigned. Design and establish workmanship criteria for projects. . Functional team member for assigned work areas to ensure product is shipped on time and per specification. Process non-conforming material reports, engineering change orders, complaints, CAPAs, and assist with training for line personnel. Performs quality on the floor audits and responsible for the maintenance and compliance with program manufacturing/quality plans.

    Responsibilities

    1. Assure Quality Assurance programs and plans are in place to provide and maintain the highest quality levels for an assigned project, product or area in accordance with contract requirements and product specifications. Assure the compliance of engineering and manufacturing program documents (good documentation practices) etc.
    2. Recommend and implement methods and procedures for evaluating the precision and accuracy of assigned products or production equipment. Responsible for product compliance with contract requirements for reliability and performance.
    3. Provide QMS support to inspection and operations personnel and establish workmanship criteria for projects, with specific emphasis on product quality audits and final QA acceptance of instruments and spares.
    4. Conduct experiments and audits to evaluate operating characteristics of products or processes. Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to systems to maintain or improve product quality.
    5. Evaluate non-conformances, corrective actions, containment, corrections, product impact, and effectiveness criteria as required. Ability to document records for compliance and defend decisions made by the business/team in audits and inspections.
    6. Analyze statistical data to evaluate trends, investigate failures completely to determine the root cause and take appropriate corrective action to prevent recurrence.
    7. Identify and correct instrumentation malfunctions, re‑designing or modifying complex test equipment, devising advanced applications of engineering technology to solve problems.
    8. Review test techniques and methods for testing company products or components on the basis of product specifications and manufacturing processes. Analyze engineering orders for the effect on test procedures.
    9. Oversee qualification and periodic testing requirements, initiating required customer reports and leading corrective action efforts on failures/defects.

    Qualifications

    BS degree preferred plus 5 or more years of related experience to be proficient in the above areas; or an equivalent combination of education and experience.

     

    Must have prior experience in Medical Device or Pharmaceutical manufacturing support. Must have FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971).

     

    Strong, demonstrated ability to think out of the box to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.

     

    Demonstrated experience working with contract manufacturing, suppliers and customers.

     

    Green Belt, Lean, Black Belt proficiency desired.

     

     

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