This position follows a hybrid model of work (Tues/Thurs in office). Position is based out of our Northfield, IL headquarter campus.

JOB SUMMARY:

Responsible for managing the quality and compliance for applicable products and processes for assigned department(s).

MAJOR RESPONSIBILITIES:

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during the investigation process.
• Identify and manage the execution of continuous improvement projects.
• Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction, in a timely manner.
• Resolve issues relating to product or production quality by interfacing with internal and external customers.
• Management responsibilities include:
  • Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
  • Day-to-day operations of a group of employees.
  • May have limited budgetary responsibility and usually contributes to budgetary impact;
  • Interpret and execute policies for departments/projects and develops.
  • Recommend and implement new policies or modifications to existing policies.
  • Provide general guidelines and parameters for staff functioning.
  • Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
  
  

COVID-19 Vaccination

Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.

Education

• Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

• At least 4 years of experience working with QSR/GMP/ISO requirements or other regulated industries.

Knowledge / Skills / Abilities

• Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS

• Experience in Medical Device, Pharmaceutical, Cosmetic, or Personal Products Industries.
• Prior experience with 510(k)s, Technical Files, Design Control, CAPAs, and Risk Managment Files.
• Prior experience supporting or participating in audits.