QA Development Program
Medline Industries, Inc.
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.
- 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
- 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
- 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
- Bachelor’s degree.
Relevant Work Experience
- 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).
- 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