Quality Development Program

Medline Industries, Inc.

Job Description

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%26rsquo;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: (1st rotation will be minimum of 9mo as it will include employee on-boarding)

  1. Regulatory Affairs/Compliance %26ndash; 6-9 months
  2. Buy/Sell Division %26ndash; 6-9 months
  3. Manufacturing Division %26ndash; 6-9 months
  4. OEM Division %26ndash; 6 months (optional)
  5. Research and Development %26ndash; 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

Job Requirements

Education

  • Bachelor%26rsquo;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

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