Principal Specialist Quality Process

Medline Industries, LP • Mundelein, IL

2d • $101,000 - $152,000

About The Position

Job Summary Lead strategic project implementation for all activities related to system management and may provide expertise and guidance for team members. Responsible for independent review of CAPA/investigation content for adequacy and compliance, including comprehensive ability to use critical thinking to evaluate events and the CAPA author team’s responses, root cause analysis, and corrective action planning. Responsible for generating direct feedback to investigation authors and their management structures, as needed, and for working with author teams to produce compliant, complete, comprehensive investigation records that adhere to Medline and industry regulatory requirements and expectations. for Quality Systems 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/regulator 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. Job Description Responsibilities: Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor. Provide feedback and drive adherence to investigation content requirements and expectations. Lead personnel and activities to establish and maintain quality systems including trending, analysis and reporting of quality metrics. Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures. Identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business. Develop, assess, and define key quality metrics/indicators to track performance and compliance. Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities. Investigate the applications of electronic documentation systems. Purchase, implement, and coordinate use of the 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. Oversee critical Quality systems projects. Develop strategy and manage the relationship with notified bodies for quality systems evaluation. Manage and coordinate Notified body/Registrar Quality Systems registration strategy. Host and coordinate Notified body/ Registrar Quality Systems audits. Support in customer and regulatory audits.

Requirements

• Bachelor’s degree in a technical or scientific discipline.
• At least 7 years of experience with medical device or pharma Quality Management Systems.
• 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).

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

• Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor.
• Provide feedback and drive adherence to investigation content requirements and expectations.
• Lead personnel and activities to establish and maintain quality systems including trending, analysis and reporting of quality metrics.
• Collect, analyze, and report quality data to track performance and compliance.
• Develop and implement improvements to processes and procedures.
• Identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business.
• Develop, assess, and define key quality metrics/indicators to track performance and compliance.
• Reviews and determine the application of various system compliance regulations.
• Ensure compliance to global regulatory requirements with internal procedures.
• Identify risk and compliance opportunities.
• Investigate the applications of electronic documentation systems.
• Purchase, implement, and coordinate use of the 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.
• Oversee critical Quality systems projects.
• Develop strategy and manage the relationship with notified bodies for quality systems evaluation.
• Manage and coordinate Notified body/Registrar Quality Systems registration strategy.
• Host and coordinate Notified body/ Registrar Quality Systems audits.
• Support in customer and regulatory audits.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees