Manager Quality Process

Job Summary Responsible for managing a team of quality process specialists as well as leading strategic implementation of items and events related to Quality Systems Management and CAPA. 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.
Supports Quality Systems related activities, analyzes problems related to quality/regulatory information, and provides systems and technical support in solving these problems.
Supports 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. 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. Identify, lead and drive opportunities to improve quality systems independently and through their team 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.
Lead CRB team in systems analysis and effectiveness measures.
Manage professional employees, including day to day operations/workload and other duties
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.
This is a working manager role - management responsibilities including, but not limited to leading day-to-day activities and outcomes of a group of employees. 
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.



 
Bachelor’s degree in a technical or scientific discipline.


Work Experience
~ At least 7 years of experience with medical device or pharma Quality Management Systems. At least 1 year of people management experience.


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, as well as potentially international).
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.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., 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.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. xrczosw Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.