Quality Process Specialist
About The Position
Under general supervision, responsible for broad 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 process related activities, analyzes problems related to quality/regulatory information, and provides systems, engineering and technical support in solving these problems. Job Description Responsibilities: Administrative management of and approvals in Medline’s document management program, as well as development and management of training associated with these processes. Support Quality process related activities, specifically as related to document control and CAPA, as well as analyze problems related to quality/regulatory information, and provide systems, engineering and technical support in solving these problems. Review document changes for adherence to regulatory and procedural requirements, as well as for appropriate training content Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures. Identify opportunities to improve quality systems and develop strategies which support the success of the business. Review and determine the application of various system regulations. Identify risk and compliance opportunities. 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.
Requirements
- Bachelor’s degree in a technical or scientific discipline.
- At least 2 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
- Administrative management of and approvals in Medline’s document management program, as well as development and management of training associated with these processes.
- Support Quality process related activities, specifically as related to document control and CAPA, as well as analyze problems related to quality/regulatory information, and provide systems, engineering and technical support in solving these problems.
- Review document changes for adherence to regulatory and procedural requirements, as well as for appropriate training content
- Collect, analyze, and report quality data to track performance and compliance.
- Develop and implement improvements to processes and procedures.
- Identify opportunities to improve quality systems and develop strategies which support the success of the business.
- Review and determine the application of various system regulations.
- Identify risk and compliance opportunities.
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
