28 days old

Quality Development Program

Medline Industries, Inc.
Northfield, IL 60093
  • Job Code
    QUA010111
Medline Industries has an immediate opening for our Quality Development Program based at our HQ in Northfield, IL. The Quality Development Program is a leadership development program that aims to recruit and develop future leaders within the Quality organization. The program builds a strong foundation on the main topics that a Divisional Quality professional and future leader would encounter, with a focus on product quality and compliance from all facets; product design and development through post-market surveillance. The program gives the employee an overall training of the Quality and Regulatory departments. The rotation is designed for a minimum of 2 years with an optional 6-month extension. After the program, the employee will be placed into a permanent position within Divisional or Manufacturing Quality Assurance. Each rotational experience is uniquely designed for a candidate and tailors their rotation to that of the department needs, the interests of the employee, and the employee's strengths. The below details are representative of the experience and responsibilities a participant in the Quality Development Program may experience.

Job Responsibilities:

Rotation Areas Within Concentration: (1 st rotation will be minimum of 9mo as it will include employee on-boarding)

  • Regulatory Affairs/Compliance - 6-9 months
  • Buy/Sell Division - 6-9 months
  • Manufacturing Division - 6-9 months
  • OEM Division - 6 months (optional)
  • Research and Development - 6 months (optional)

  • Regulatory Affairs & Compliance:
    • 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 US and international regulatory frameworks for medical devices, including device classifications, regulatory pathways, submission requirements, and formulation of regulatory strategies
    • Participate in performing assessments of proposed changes to existing products to determine regulatory impact
    • Assist in drafting/compiling regulatory submissions pertaining to product clearances/approvals (i.e. 510(k)s and CE technical files) to gain familiarity with the review process and understand common submission risks
    • Understand the requirements of drug and device regulations, including 21 CFR 820, 21 CFR 211, and ISO 13485
    • Learn the basics of auditing and actively participate in performing internal and supplier audits
    • Gain experience with writing for a regulatory audience

    Buy/Sell Division:
    • Create and maintain Device Master Records (DMR) for product families sold by the Division
    • The ability to perform all steps involved in the creation and maintenance for Design History Files (DHF) for any medical devices requiring per FDA or ISO regulations
    • Create and maintain 510k files for submission and subsequent audits to the Regulatory team
    • Understand and perform product FMEAs
    • The ability to initiate and follow any Product Change Notices through the entire process
    • 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

    OEM Division:
    • Understand the role of Medline as a Contract Manufacturer for an OEM Account
    • Create and execute Project Charters for OEM project(s)
    • Understand and be able to prepare a Complaint Investigation Summary that provides the OEM customer the information they need to close out their Supplier Corrective Action Request (SCAR)
    • Support customer audit(s)

    Research and Development:
    • Project Management
      • Learn key facets of agile project management
      • Identify project stakeholders
      • Develop project timelines w/ contingency planning
      • Develop test matrices
    • Product Development (Design)
      • 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 manufacturers
    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
    • Experience with government and industry quality assurance requirements and standards.
    • Position requires up to 15% travel






    Posted: 2021-04-08 Expires: 2021-05-07
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    Quality Development Program

    Medline Industries, Inc.
    Northfield, IL 60093

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