Medline Industries has an immediate opening for Quality Process Specialist at our manufacturing facility in Arlington Heights, IL. Under general supervision, responsible for broad Quality process design, integration, implementation, and maintenance. Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Support Quality process related activities, analyzes problems related to quality/regulatory information, and provides systems, engineering and technical support in solving these problems.
MAJOR RESPONSIBILITIES:
Administer and maintain quality systems.
Collect, analyze, and report quality data to track performance and compliance.
Develop and implement improvements to processes and procedures.
Identify opportunities to improve quality systems and develop strategies which support the success of the business.
Review and determine the application of various system regulations. Identify risk and compliance opportunities.
Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
Execute responsibilities as CRB team member. Lead CRB team in systems analysis and effectiveness measures.
Train and coach personnel to deliver optimal results based on the department's goals.
Education
Bachelor's degree in a technical or scientific discipline.
Work Experience
At least 2 years of experience with medical device or pharma Quality Management Systems.
Knowledge / Skills / Abilities
Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).
Proficiency in Microsoft Suite, MS Visio, MS Project, Minitab.
Position requires travel up to 10% of the time for business purposes (within state and out of state).
PREFERRED JOB REQUIREMENTS
Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions.
Experience with quality systems development and implementation.
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
Experience in the Medical Device and Pharmaceutical industry.
