QA Development Program

Medline Industries, Inc.

Job Description

Medline Industries has an immediate opening for our Quality Development Program. This individual will rotate within Quality organization to gain a broad variety of quality experience and leadership development.  The program builds a strong foundation on the main topics that a Divisional Quality Engineer would encounter, with a focus on product quality and compliance from all facets; concept through post-market surveillance.  The program gives the employee an overall training of the QA/RA departments and tailors their rotation to that of the department needs, the interests of the employee, and the employee’s strengths.

Job Responsibilities:

Regulatory Affairs:

  • Learn the basics of auditing and show a competent understanding of the device and/or drug regulations in order to be a lead auditor
  • Understand the fundamentals of 510k and CE files; and help write/compile submissions
  • Be able to perform basic sterilization validations and other sterilization related tasks

Buy/Sell Division:

  • Create and maintain 510k files for submission and subsequent audits to the Regulatory team.
  • Create and maintain Device Master Files (DMF) for product families sold by the Division
  • The ability to perform all steps involved in the creation and maintenance for Design Files for any medical devices requiring per FDA or ISO regulations
  • Understand and perform product FMEAs
  • The ability to initiate and follow any Change Notices through the entire process to include releasing and training if required
  • To be able to determine when a deviation is required and how-to create and approve deviations and when to escalate when functional reasons are involved
  • To have a thorough understanding of the complaint process including investigating, trending, corrective actions and communications to the customer/sales rep
  • Prepare reports to communicate involvement and results of quality assurance activities

Manufacturing Division:

  • Understand when and why a validation is required to include IQ/OQ/PQ and all the steps necessary for a complete and thorough validation
  • Learn the basics of Incoming inspection (the process and how specs/instructions get implemented to the inspection team
  • Understand and perform process FMEAs
  • Learn the basics of product inspection, router instructions, sense of urgency based on how defects can stop a production line
  • Understand the FDA and ISO expectations of Production and Process Controls, proper documentation, etc.
  • Apply statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
  • Understand how specs become work instructions, how work instructions become router, PPF, etc.  Understand what is needed from a Quality, Manufacturing, Engineering, and Operations standpoint to take a concept to production.

Research and Development: 

  • Utilize CAD software to develop models, technical drawings, PCB layouts, or software architectures
  • Create new product designs, generate/evaluate prototypes, and produce technical drawings/specifications
  • Collaborate with product divisions to identify user needs and develop product requirements, performance attributes, and quality specifications
  • Work with legal to design and implement new intellectual property
  • Collaborate with domestic and international manufacturer

    Job Requirements

    Education

    • Bachelor’s degree.

    Relevant Work Experience

    • At least 1 year of professional experience.
    • Will consider related internships and/or related student employment

    Additional

    • Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions
    • Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects
    • Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
    • Experience using MS Office Suite products (Word, Excel, Powerpoint, Outlook).

    PREFERRED QUALIFICATIONS

    • Bachelor's degree in Engineering, Science, or Technical Field.
    • Experience with government and industry quality assurance requirements and standards.
    • Position requires up to 15% travel
    Apply