Quality Development Program
Medline Industries, Inc.
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.
Rotation Areas Within Concentration: (1st rotation will be minimum of 9mo as it will include employee on-boarding)
- Regulatory Affairs/Compliance %26ndash; 6-9 months
- Buy/Sell Division %26ndash; 6-9 months
- Manufacturing Division %26ndash; 6-9 months
- OEM Division %26ndash; 6 months (optional)
- Research and Development %26ndash; 6 months (optional)
- 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
- 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
- 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
- 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)
- 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
- Bachelor%26rsquo;s degree.
- At least 1 year of professional experience.
- Will consider related internships and/or related student employment
- 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).
- Experience with government and industry quality assurance requirements and standards.
- Position requires up to 15% travel