Manager Quality Process & Systems
About The Position
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.
Requirements
- Bachelor’s degree in a technical or scientific discipline.
- 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).
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
- 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 for team and Medline.
- 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.
- 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.
- 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.
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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
