AddressJOB SUMMARY:
Under general supervision, responsible for broad Quality process design, integration, implementation, and maintenance.
Support management of the Quality data integrity for Medline products, processes, and programs including but not limited to, CAPA, Document Control, and Training related 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.
MAJOR RESPONSIBILITIES:
- Administer and maintain quality systems - specifically systems as related to Document Control and aspects of the CAPA system
- Collect, analyze, and report quality data to track performance and compliance - specifically Document Control and document training metrics
- Develop and implement improvements to processes and procedures - specifically participate in identifying and implementing opportunities to streamline how documents are assigned for training, leveraging the capabilities of the existing EtQ Reliance program and participate in identification and implementation of other team efficiency improvements.
- 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 in the CAPA module to support CRB team responsibilities. Participate with CRB team in systems analysis and effectiveness measures.
- Train and coach personnel to deliver optimal results based on the department’s goals.
Education
- Bachelor’s degree in a technical or scientific discipline.
Work Experience
- At least 2 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).
- 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).
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.
