Senior Quality Process Specialist

JOB SUMMARY:

This position is a WFH (work from home) opportunity. Candidate needs to be located in Chicagoland area or Southeast Wisconsin and able to commute into Northfield headquarters location when necessary.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.

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.
• Identifies and advises 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
• Reviews 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. Supports in customer and regulatory audits.
• Provide project guidance, training, and coaching.

Education

• Bachelor's degree in a technical or scientific discipline.

Work Experience

• At least 4 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).
• Position requires travel up to 10% of the time for business purposes (within state and out of state)

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

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