Sr. Quality Process Specialist

Medline Industries, LP • Mundelein, IL

71d • $85,280 - $123,760

About The Position

Under minimal supervision, responsible for 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 Systems related activities, analyzes problems related to quality/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with internal and external inputs to develop these solutions.

Requirements

• Bachelor’s degree in a technical or scientific discipline.
• At least 4 years of experience with medical device or pharma Quality.
• 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.

Nice To Haves

• 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.
• Experience hosting FDA/ISO GMP inspections.
• Experience with SAP.
• Experience with ETQ Reliance.

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 and advise opportunities to improve quality systems and develop long-term strategies that support the success of the business.
• Determine and create key quality metrics/indicators to track performance and compliance.
• Review and determine the application of various system compliance regulations.
• Ensure compliance to global regulatory requirements with internal procedures.
• Identify risk and compliance opportunities.
• Implement and coordinate use of electronic documentation systems and training personnel.
• 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.
• Support hosting Notified body/ Registrar Quality Systems audits.
• Support in customer and regulatory audits.
• Provide project guidance, training, and coaching.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees