Job Description

Sr. Quality Assurance Manager – Nypro Gurnee

Requisition Number: 210282
Work Location: Gurnee, IL

Job Summary

  • Serves as the Management Representative for the site, as defined in the following Quality Management System standards & regulations:
    • ISO 9001 Quality management systems – Requirements
    • ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
    • 21 CFR Part 820 Quality System Regulation
  • Manages the quality unit, executing all functions to fulfill quality assurance requirements to maintain regulatory compliance
  • Position reports directly to the Director Quality Operations – North America for all responsibilities and performance defined within.
  • Position has a dotted-line responsibility to the site General Manager for day-to-day operational, manufacturing and quality responsibilities and support.

Essential Duties & Responsibilities

  • Lead the Quality Assurance Department in operating with a high level of efficiency, integrity and enthusiasm, striving to achieve excellence in all endeavors.
    • Recruit and maintain a high-caliber staff appropriate to business circumstances.
    • Develops, motivates and challenges all team members to perform to their full potential, providing direct and timely feedback in formal and informal media.
    • Evaluates and schedules appropriate training programs and/or seminar for the Quality Assurance staff, including direct employees.
    • Delegates and organizes departmental workload according to project assignments.
  • As a member of the site Management Team, be a creative and proactive contributor to bolster process & quality continuous improvement.
    • Provides input to and support of plant and company safety initiatives.
    • Co-ordinates interaction between the Quality Department and all other manufacturing and support functions.
    • Monitors Quality Engineering and Supplier Engineering activities and their impact on the continuous improvement of process yields and efficiencies.
  • Serve as an effective business partner
    • Support Business Unit Managers / Directors, providing leadership and direction for quality initiatives and business strategic plans
    • Provide representation for site quality function for Nypro Healthcare customers.
    • Supports financial budgeting, TM1 resource allocation responsibilities and reporting for the site
  • Establish and maintain effective measures for assuring product quality
    • Oversees the effectiveness of up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.
    • Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
    • Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
    • Monitor the product acceptance levels (yields) as seen by the customer and ensure that appropriate preventive measures are taken.
    • Maintain plant Master Validation Plan (MVP), as needed, for product that will be used in an FDA regulated market. Ensure conformity of initial and ongoing validations performed in support of the GMP quality systems.
    • Generate and maintain applicable quality system documentation, as needed. Documents such as Device Master Record (DMR), Design History File (DHF), validation protocols, for example, and other specified documents in support of customer projects.
  • Serve as Management Representative for the site Quality Management System:
    • Ensuring all processes needed for the quality management system are established implemented and maintained, including validation, document control, audit.
    • Promote the Quality Policy and enable a quality culture to ensuring awareness of customer requirements throughout the organization.
    • Reporting to top management on the performance of the quality management system and any need for improvement through periodic Management Review
    • Act as liaison with external parties on matters relating to the QMS.
  • Other responsibilities may be assigned from time to time as directed by Nypro Healthcare Leadership, based on company needs.

Education & Experience Requirements

  • Bachelor’s Degree in Science, Biomedical, Engineering, Clinical or equivalent
  • 10+ years of relevant experience within drug, medical device, IVDD or related industries
  • Professional certifications preferred, such as CQM/OE, CQE, CQA, CSSBB, PMP
  • Excellent verbal and written communications skills
  • Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
  • Some overnight travel is required

Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.

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