Sr. QA Manager – Capital & Therapy Product Division

Quality Management role with growth potential, leading QA Engineering teams for two newly established product divisions: Capital and Therapy Products. Product lines include, but not limited to: crash carts, solution stands, mayo stands and other capital equipment, patient lifts, Orthopedic Soft Goods, Mobility Aids, Therapy Supplies.

Responsible for leading the quality and compliance for applicable products and processes for afore mentioned product divisions. This position follows a hybrid model of work (Tues/Thurs in office). Position is based out of our Northfield, IL headquarter campus.

MAJOR RESPONSIBILITIES:

• Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Act as liaison with the Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Devise and implement effective communication strategies with Divisions, Suppliers, Manufacturing, and/or Operations Executives and other internal and external Stakeholders.
• Leads the process and team during investigations and identifying resolutions for issues relating to product or production quality by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.
• Devise and implement continuous improvement initiatives, develop and share best practices, and participate in policy setting activities.
• Oversee the execution to the resolution of all quality issues.
• Provides Leadership support during internal/external regulatory audits.
• Management responsibilities include:
  • Typically, manages through multiple Managers and/or Supervisors
  • Oversee major projects/programs/outcomes;
  • Budget responsibility;
  • 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 5 years of experience working with QSR/GMP/ISO requirements or other regulated industries.
• At least 2 years of management experience.

Knowledge / Skills / Abilities

• Experience analyzing and reporting data and performing statistical analysis 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 skill level in Microsoft Excel (for example: pivot tables and reporting, conditional formatting, tables, formulas, charting, etc.).
• Position requires travel up to 15% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.